FAC-4 - Class B & Supplemental FA - 4 Shelf Cabinet
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- FAC-4 - Class B & Supplemental FA - 4 Shelf Cabinet FDA UDI
- Generic Name
- Non-rebreathing valve, single-use FDA UDI
- Device Name
- FAC-4 - Class B & Supplemental FA - 4 Shelf Cabinet FDA UDI
- Model / Reference
- K615-031 FDA UDI
- Description
- FAC-4 - Class B & Supplemental FA - 4 Shelf Cabinet FDA UDI
Identifiers
- Catalog Number
- K615-031 FDA UDI
- Primary DI / UDI-DI
- 00766588150314 FDA UDI
- FDA Product Code
- KGX FDA UDIIMD FDA UDIHMP FDA UDILRR FDA UDIEFQ FDA UDICBP FDA UDI
- GMDN Term
- Non-rebreathing valve, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 FDA UDI890.5710 FDA UDI878.4440 FDA UDI868.5870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: First aid kit, medicatedAdhesive bandageNon-woven gauze padWound-nonadherent dressing, absorbent, non-antimicrobial
The FAC-4 Class B & Supplemental FA - 4 Shelf Cabinet is a non-rebreathing valve used in various medical applications, including resuscitation and post-operative care. This single-use device features unidirectional valves made of various materials (e.g., silicone, rubber) that open and close with each inspiration/expiration to prevent patient rebreathing of exhaled gases.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Certified Safety Manufacturing, Inc.
Sources (1)
- FDA UDI 0633405d-1bb4-4930-9d36-70bf10c87b71 35 fields · synced Jul 24, 2026