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An endotracheal tube holder is a single-use device that keeps an endotracheal (ET) tube from shifting once it is in place, usually with straps, cloth ties, pinch rings or a Velcro band. In the United States it is a Class I device under 21 CFR 868.5770 (FDA product code CBH). This page explains what the product class is, how the main types differ, and how it is regulated. Readers are clinic and hospital staff, supply buyers and students.
This page describes products and general use; it is not medical advice.
What an endotracheal tube holder is
The federal regulation defines a tracheal tube fixation device as “a device used to hold a tracheal tube in place, usually by means of straps or pinch rings” (21 CFR 868.5770(a), checked 2026-10-30). The Global Medical Device Nomenclature (GMDN) term 35815, “Endotracheal tube holder”, describes a device that holds and stabilizes an ET tube once it has been placed. It notes that the device may include a teeth protector, that it typically consists of straps, pinch rings, cloth ties or Velcro bands, and that it allows easy readjustment of the tube without retaping or safety pins. GMDN lists it as a single-use device (as shown in the FDA AccessGUDID device records, checked 2026-10-30).
Who uses it: clinicians who manage a patient’s airway, including neonatal and pediatric care (some records are labeled for that population). FDA files the product code under the anesthesiology review panel.
How it is built
Holders fall into three construction families. Strap or tie holders use cloth or fabric bands around the head or neck. Pinch-ring or clamp holders grip the tube itself. Adhesive-tape products use a cloth strip applied to the tube and face. Some records add a cushion or a teeth protector. Adhesive bases are also listed as separate accessories, for example “Dale Adhesive Base for Dale 270 and 280”.
Types of endotracheal tube holders
The table groups real device records in the FDA UDI database (openFDA, product code CBH, checked 2026-10-30). Each row names a record, not a recommendation.
| Type | Record wording | Key difference |
|---|---|---|
| Strap or holder with adhesive base | Dale Endotracheal Tube Holder; Dale Adhesive Base “for Dale 270 and 280” | Holder and adhesive base are separate records |
| Adhesive tape strip | Marpac “adhesive tape strip, adult, cloth fabric”; “adhesive precut tape strip, neonatal/pediatric, size 1” (box of 25) | Tape applied to tube and face; adult and neonatal/pediatric versions are listed separately |
| Non-adhesive on the face | Marpac “adjustable, adult, NO adhesive on patient face”; adult XL / burn-patient version | Record states no adhesive contacts the patient’s face |
| Long-term holder | ET Tape “Long Term Endotracheal Tube Holders, 50 units” | Labeled for long-term use in the record |
| Pediatric and neonatal | NeoBar: “intended to secure an endotracheal tube … for use on pediatric (neonates, infants and children) patients” | Population stated in the intended-use description |
| Oral fastener | AnchorFast Guard: “Oral Endotracheal Tube Fastener” | Specified as oral |
| Airway-device holder | Laerdal Thomas Tube Holder Adult: secures “Endotracheal Tubes and Supraglottic Airway devices” | Record covers more than one airway device type |
FDA classification and regulation
- Regulation: 21 CFR 868.5770, “Tracheal tube fixation device” (Cornell LII copy of the eCFR, checked 2026-10-30).
- Class I (general controls). The regulation exempts it from premarket notification (510(k)), subject to the limitations in 21 CFR 868.9.
- openFDA classification record (last updated 2026-10-19): product code CBH, device name “Device, Fixation, Tracheal Tube”, review panel Anesthesiology, not implanted, not life-sustaining or life-supporting, and not exempt from good manufacturing practice (GMP) requirements (gmp_exempt_flag N).
Product code CBH also includes tracheostomy neck-strap holders (for example Dale PediPrints and several Marpac “trach tube holder” records), which are a different product. For tracheostomy products see tracheostomy collars and what a tracheostomy tube is.
Sizes
At least two ET-holder product families in the FDA UDI data (openFDA UDI records under product code CBH, checked 2026-10-30) state the tube sizes they fit. Most other holder records are described by population (adult, adult XL, neonatal/pediatric) rather than a tube diameter.
| Product family | Size wording in the UDI record |
|---|---|
| Dale Endotracheal Tube Holder | “Fits ET Tube sizes 7.0mm – 10.0mm” |
| SolidAIRity Flex (single-strap and dual-strap; GMDN 35815, oral ET tube stabilizer) | “Fits ETT Sizes 7.0mm-8.5mm (I.D.) / 9.3mm-11.8mm (O.D.)” |
This table lists only records that state a size; it is not a complete size chart, and I.D. and O.D. are the tube’s inner and outer diameters. For how tube-related airway equipment is sized, see oral airway sizes, laryngeal mask airway sizes and Macintosh blade sizes.
How to choose
The regulation sets no selection criteria. Device records show three attributes to check on a specific product’s label before it is stocked:
- Latex. Latex labeling is a field on each record and it differs between products. One adult Marpac cloth tape strip record reads “CONTAINS LATEX”, while the Dale, Locktite, ET Tape and NeoBar records are labeled as not made with natural rubber latex. The label on the specific product governs.
- Intended population. Some records are labeled adult, adult XL or neonatal/pediatric.
- Single use. The FDA records for this product class are labeled single-use.
Safe use and handling basics
Follow the manufacturer’s instructions for use for the exact product. Because these devices are labeled single-use, nothing in the regulation or device records supports reusing one on another patient. Securing technique is clinical training and is outside this page.
Common mistakes
- Treating a tracheostomy neck holder as an ET tube holder. They share FDA product code CBH but are separate products.
- Assuming every holder is latex-free. The records differ.
- Overlooking the labeled population. The records label adult, adult XL and neonatal/pediatric products separately.
Supplies for emergency care are listed in the emergency and trauma supplies category.
Frequently asked questions
What is an endotracheal tube holder?
A single-use device that holds and stabilizes an endotracheal tube once placed, typically with straps, pinch rings, cloth ties or Velcro bands (GMDN term 35815, checked 2026-10-30).
Is an endotracheal tube holder an FDA-regulated device?
Yes. It is a Class I device under 21 CFR 868.5770, exempt from 510(k) premarket notification subject to 21 CFR 868.9 (checked 2026-10-30).
Do all endotracheal tube holders contain latex?
No. Latex labeling differs between records, so the label on the specific product governs.
Is a tracheostomy tube holder the same product?
No. It shares FDA product code CBH but is a different product; see tracheostomy collars.
Sources
- 21 CFR 868.5770, Tracheal tube fixation device: https://www.law.cornell.edu/cfr/text/21/868.5770 (checked 2026-10-30)
- openFDA device classification, product code CBH: https://api.fda.gov/device/classification.json?search=product_code:CBH (checked 2026-10-30)
- openFDA UDI / AccessGUDID records, product code CBH, including GMDN 35815: https://api.fda.gov/device/udi.json?search=product_codes.code:CBH (checked 2026-10-30)
