Identity
- Trade Name
- Pertrach FDA UDI
- Generic Name
- Cricothyrotomy kit, single-use FDA UDI
- Model / Reference
- 301-D4550 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841470104399 FDA UDI
- 510(k) Number
- K914743 FDA UDI
- FDA Product Code
- BTO 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 5.6 Millimeter FDA UDI
Category: Cricothyrotomy kit, single-use
Pertrach by Engineered Medical Systems, LLC — 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
- Stradis Medical, LLC — STRADIS MEDICAL, LLC
- TACTICAL CricKIT — NORTH AMERICAN RESCUE, LLC. · Class II
Cleared under the same submission
K914743 also covers:
- Pertrach — Engineered Medical Systems, LLC
- Pertrach — Engineered Medical Systems, LLC
- Pertrach — Engineered Medical Systems, LLC
- Pertrach — Engineered Medical Systems, LLC
- Pertrach — Engineered Medical Systems, LLC
- Pertrach — Engineered Medical Systems, LLC
- Pertrach — Engineered Medical Systems, LLC
- Pertrach — Engineered Medical Systems, LLC
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Pertrach — Pulmodyne Inc.
- Pertrach — Pulmodyne Inc.
- Pertrach — Pulmodyne Inc.
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
- Engineered Medical Systems, LLC
Sources (1)
- FDA UDI ba661696-8444-4d96-81a6-d5287789bd1e 35 fields · synced Jun 8, 2026