Identity
- Trade Name
- b.pure FDA UDI
- Generic Name
- Skin surface device adhesive FDA UDI
- Device Name
- BLEMISH PATCHES FDA UDI
- Model / Reference
- 64430233E FDA UDI
- Description
- BLEMISH PATCHES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00049696507721 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Skin surface device adhesive FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin surface device adhesive
b.pure by Fourstar Group Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Skin surface device adhesive.
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- Protecta-Gel® — J.R.J. MEDICAL INNOVATIONS, LLC · Class I
- POPS — TRIFECTA THERAPEUTICS LLC · Class I
- HYGITECH — HYGITECH · Class I
- ViveCare — VIVE HEALTH LLC · Class I
- ViveCare — VIVE HEALTH 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
- Fourstar Group Inc.
Sources (1)
- FDA UDI 1dba064a-2492-4d73-a871-4b3e0ae6dc0c 33 fields · synced Jun 8, 2026