Identity
- Trade Name
- Melker FDA UDI
- Generic Name
- Cricothyrotomy kit, single-use FDA UDI
- Device Name
- Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous FDA UDI
- Model / Reference
- G47663 FDA UDI
- Description
- Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous FDA UDI
Identifiers
- Catalog Number
- C-TCCSB-500-01 FDA UDI
- Primary DI / UDI-DI
- 00827002476639 FDA UDI
- 510(k) Number
- K160200 FDA UDI
- FDA Product Code
- JOH FDA UDI
- GMDN Term
- Cricothyrotomy kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Cricothyrotomy kit, single-use
Melker by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cricothyrotomy kit, single-use.
- Motion Medical Distributing — Haslam Medical, Inc. · Class II
- Motion Medical Distributing — Haslam Medical, Inc. · Class II
- NAR — NORTH AMERICAN RESCUE, LLC. · Class II
- TACTICAL CricKIT — NORTH AMERICAN RESCUE, LLC. · Class II
- H&H Emergency Cricothyrotomy Kit — H & H Medical Corporation · Class II
- Motion Medical Distributing — Haslam Medical, Inc. · Class II
- Pertrach — Engineered Medical Systems, LLC · Class II
- Stradis Medical, LLC — STRADIS MEDICAL, LLC
Cleared under the same submission
K160200 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 748c8304-bada-43f1-b38a-18fd4c4fb78d 37 fields · synced Jun 8, 2026