Identity
- Trade Name
- 16PW - Delivery Truck - Poly White FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- 16PW - Delivery Truck - Poly White FDA UDI
- Model / Reference
- K614-046 FDA UDI
- Description
- 16PW - Delivery Truck - Poly White FDA UDI
Identifiers
- Catalog Number
- K614-046 FDA UDI
- Primary DI / UDI-DI
- 00766588140469 FDA UDI
- FDA Product Code
- CBP FDA UDIKGX FDA UDIEFQ FDA UDILRR FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5870 FDA UDI880.5240 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: First aid kit, medicatedAdhesive bandageNon-woven gauze padWound-nonadherent dressing, absorbent, non-antimicrobial
16PW - Delivery Truck - Poly White by Certified Safety Manufacturing, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-woven gauze roll/sheet.
- Walgreens — WALGREEN CO. · Class I
- Exchange Select — Aafes · Class I
- Dermacea — Cardinalhealth · Class I
- 5403 Bandages and Supplies — SIGVARIS, INC. · Class I
- 5438 Bandages and Supplies — SIGVARIS, INC. · Class I
- 5054 Bandages and Supplies — SIGVARIS, INC. · Class I
- 5300 Bandages and Supplies — SIGVARIS, INC. · Class I
- 5057 Bandages and Supplies — SIGVARIS, INC. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Certified Safety Manufacturing, Inc.
Sources (1)
- FDA UDI d20d64c4-c765-4778-b63f-a228bf6a805b 35 fields · synced May 30, 2026