Identity
- Trade Name
- 10PW - Head Start - Poly White FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- 10PW - Head Start - Poly White FDA UDI
- Model / Reference
- K610-093 FDA UDI
- Description
- 10PW - Head Start - Poly White FDA UDI
Identifiers
- Catalog Number
- K610-093 FDA UDI
- Primary DI / UDI-DI
- 00766588100937 FDA UDI
- FDA Product Code
- KGX FDA UDIIMD FDA UDILRR FDA UDICBP FDA UDIEFQ FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 FDA UDI890.5710 FDA UDI868.5870 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 padDressing-fixation skin adhesive tape, non-silicone
10PW - Head Start - Poly White by Certified Safety Manufacturing, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Certified Safety Manufacturing, Inc.
Sources (1)
- FDA UDI acfd5706-e5f2-4bbf-971c-364a8468bd33 35 fields · synced May 30, 2026