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Cric Kit: Contents, FDA Classification and What to Check

Cric kit (cricothyrotomy kit) contents listed by two manufacturers, its FDA classification, and the documents to request. General product information only.

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General product information only, not medical advice. This page describes what manufacturers and regulators say a cricothyrotomy kit (cric kit) contains and how it is classified. It does not describe how to use one; technique and training follow your own protocol and the manufacturer’s instructions for use.

A cric kit is a packaged set of items for emergency surgical airway access. Searchers are usually a clinician, EMS or clinic supply lead, or purchaser who needs to know what is normally inside, how FDA classifies it, and which documents to ask a supplier for. Contents below are taken from two named kit listings; they are not a universal standard.

Purpose and setting

FDA lists the product as “Cricothyrotomy Kit” under product code OGP, Class 2, regulation 21 CFR 868.5800 (tracheostomy tube and tube cuff), medical specialty Anesthesiology, premarket route “enforcement discretion”. The same terms are used for both “cric kit” and “cricothyrotomy kit”. Kits sit alongside other airway supplies such as the endotracheal tube and laryngeal mask airway, which have separate roles and records.

Checklist table: contents listed by two manufacturers

Quantities below are as each source lists them (checked 2026-11-03). Blank means that source does not list the item.

Category Item H&H Emergency Cricothyrotomy Kit (HHECT01) North American Rescue BAC-Pack Notes
Cutting Scalpel, #10 blade 1 (disposable) 1 (protected) Blade number is the same in both listings.
Access Tracheal hook 1 1 Listed by both.
Access Curved Crile hemostat 1 Only the H&H listing includes it.
Airway tube Cuffed tube 1 endotracheal tube, 6.0 mm cuffed 1 tracheostomy tube with bougie-introducer, flexible, cuffed, 6 mm Tube type differs: endotracheal in one, tracheostomy in the other.
Guide Bougie 1 (35 cm), separate item Integrated with the tube as a bougie-introducer Separate bougie versus bougie packaged with the tube.
Cuff Syringe, 10 cc / 10 mL 1 (10 cc) 1 (10cc) Listed by both.
Securing Twill tape or tube securing strap 1 twill tape 1 tube securing strap Different securing item in each.
Prep and dressing Alcohol pad 1 listed The manufacturer’s description text gives a different count, so confirm against the packing list you receive.
Prep and dressing Gauze, 4 in. x 4 in., 2-pack 1 pack Only the BAC-Pack lists it.
Packaging Nylon pouch 1 Packaged size listed as 8 in. x 4 in. x 1.75 in., 5.2 oz.

The H&H record describes the kit as a one-time-use sterile emergency airway kit. The BAC-Pack page states that the safety scalpel, tube and syringe are provided sterile. Both lists show that “cric kit” is not one fixed parts list, so compare the contents of the specific product against your own protocol rather than assuming a standard set.

What varies by facility type

Neither manufacturer source sets contents by facility type. What the sources do show is variation by product: a compact pouch (BAC-Pack, which the manufacturer describes as usable in any environment) versus a kit that includes a separate hemostat and bougie (H&H). Which items a facility stocks, where kits are carried and who checks them are set by the facility’s own protocol and scope of practice. For how this fits with other stocked items, see the EMS equipment guide, the crash cart guide and the outpatient emergency cart checklist.

Storage, expiry and restocking

The H&H GUDID record does not state a shelf life, and the BAC-Pack page does not list one either. For a sterile single-use kit, the expiry date is printed on the label (in UDI terms it is a production identifier), so record that date for each kit received. The H&H record marks the kit as single-use, so a used or opened kit is replaced rather than repacked. For a restocking routine, see the EMS jump bag restocking checklist; adapt it to the manufacturer’s storage instructions in the IFU.

Standards and rules that apply

  • 21 CFR 868.5800 (tracheostomy tube and tube cuff): Class II, 51 FR 40389, November 6, 1986. Checked 2026-11-03.
  • FDA product code OGP, “Cricothyrotomy Kit”: Class 2. FDA’s classification entry says the code was established under the May 20, 1997 convenience kits interim regulatory guidance; this type of convenience kit is under enforcement discretion and does not require a 510(k) if it meets all criteria in that guidance. Checked 2026-11-03.
  • FDA product code BWC, “Needle, Emergency Airway”: Class 2, 21 CFR 868.5090, flagged life-sustaining/life-supporting, GMP exempt flag “N”. Some emergency airway products may be classified under this code rather than OGP, so check which code a supplier cites.
  • NLM AccessGUDID record 00857048006002: kit: yes; single use: yes; prescription use: yes; product code OGP; natural rubber latex labeling flag: no. Checked 2026-11-03.

Documents worth requesting from a supplier, based on what the records above carry: the instructions for use, the UDI device identifier and GUDID record, the regulatory basis (a 510(k) number or the convenience-kit basis), the sterility statement and expiry date, and the component list for the exact catalog number.

FAQ

What is a cric kit?

A cric kit, or cricothyrotomy kit, is a packaged set of sterile items for emergency surgical airway access. FDA lists it as “Cricothyrotomy Kit”, product code OGP, Class 2.

Is a cric kit sterile and single-use?

The H&H record describes a one-time-use sterile kit and lists it as single use; the BAC-Pack page states its scalpel, tube and syringe are provided sterile. Confirm for any other product from its IFU.

Does a cric kit need a 510(k)?

FDA’s OGP entry says kits of this convenience-kit type are under enforcement discretion and need no 510(k) if they meet all criteria in the 1997 guidance. Kits cleared under another code, such as BWC, follow that code’s route. Ask the supplier which basis applies.

What is usually in a cric kit?

Both kits above list a #10 scalpel, a tracheal hook, a cuffed tube of about 6 mm, a 10 cc syringe and a securing tape or strap. Other items, such as a hemostat, gauze or a separate bougie, differ by product.

Sources

Related supplies: respiratory supplies.

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