Identity
- Trade Name
- ARC Medical FDA UDI
- Generic Name
- Patient-end respiratory anaesthesia kit FDA UDI
- Device Name
- 72 Circuit with 2L Bag Latex Free FDA UDI
- Model / Reference
- X72LF2 FDA UDI
- Description
- 72 Circuit with 2L Bag Latex Free FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810050854016 FDA UDI
- FDA Product Code
- OFP FDA UDI
- GMDN Term
- Patient-end respiratory anaesthesia kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Patient-end respiratory anaesthesia kit
ARC Medical by Typenex Medical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient-end respiratory anaesthesia kit.
- Ultipor™ Anesthesia Breathing Circuit System - Patient Kit — Global Life Sciences Solutions USA LLC · Class II
- Ultipor™ Anesthesia Breathing Circuit System - Patient Kit — Global Life Sciences Solutions USA LLC · Class II
- Ultipor™ Anesthesia Breathing Circuit System - Patient Kit — Global Life Sciences Solutions USA LLC · Class II
- Ultipor™ Anesthesia Breathing Circuit System - Pediatric size Patient Kit — Global Life Sciences Solutions USA LLC · Class II
- ARC Medical — Typenex Medical, LLC · Class I
- ARC Medical — Typenex Medical, LLC · Class I
- ARC Medical — Typenex Medical, LLC · Class I
- ARC Medical — Typenex Medical, LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Typenex Medical, LLC
Sources (1)
- FDA UDI fa880f6d-4e0a-4cec-8791-c56d6efb55b0 35 fields · synced May 30, 2026