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Forward Field Cricothyrotomy Kit with Bougie
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Synchronis Medical LLC, United States |
|---|---|
| FDA product code | OGP |
| Device type | Cricothyrotomy Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-12-31 |
| Record revised | 2023-05-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 12, pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4818-32008 | In distribution | |
| 4818-32006 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Motion Medical Distributing | Haslam Medical, Inc. | 25 |
| Curaplex | Bound Tree Medical, LLC | 23 |
| NAR | North American Rescue, LLC. | 13 |
| Tactical CricKIT | North American Rescue, LLC. | 9 |
| Cardinal Health | Cardinal Health 200, LLC | 8 |
| NAR Kit | North American Rescue, LLC. | 5 |
| Endotracheal Kit | NAR Medical Depot, LLC | 2 |
| H&H Emergency Cricothyrotomy Kit | H & H Co. | 1 |
| TMM-CR-SO (Tactical Medical Module – Cricothyroidotomy Special Operations) | Altitude Technologies Inc. | 1 |
| Emergency Cric Kit | Safeguard US Operating, LLC | 1 |
| ReadyCric Kit | H & H Co. | 1 |
| TMM-BCR-Tactical Medical Module Bougie Assisted Cricothyrotomy | Altitude Technologies Inc. | 1 |
Showing 12 of 22. All products under Cricothyrotomy Kit
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.