Identity
- Trade Name
- ASP MEDICAL FDA UDI
- Generic Name
- Surgical/examination garment kit FDA UDI
- Device Name
- BOUFFANT, CAP BLUE 21" 1/EA, 100/BX, 1,000/CS (10BX/CS) FDA UDI
- Model / Reference
- HWA201 FDA UDI
- Description
- BOUFFANT, CAP BLUE 21" 1/EA, 100/BX, 1,000/CS (10BX/CS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840216105362 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Surgical/examination garment kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical/examination garment kit
Asp Medical by Asp Global, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/examination garment kit.
- Lab Coats Knitted Cuffs & Collar with Pockets, 2X-Large, White — Dynarex Corp. · Class I
- GRYPHON BRANDS — Gryphon Brands Inc. · Class I
- GRYPHON BRANDS — Gryphon Brands Inc. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Centurion — Centurion Medical Products · Class II
- VR — POLYCONVERSIONS, INC. · Class I
- VR — POLYCONVERSIONS, INC. · Class I
- Safehand — Winsight International Solutions, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Asp Global, LLC
Sources (1)
- FDA UDI c6a16c2f-47d6-43c6-b7c4-c67e57697e00 33 fields · synced Jun 8, 2026