Identity
- Trade Name
- PRIMO FDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
- Device Name
- 72" Gait Belt, Quick Release Buckle, Natural FDA UDI
- Model / Reference
- GB72QRN FDA UDI
- Description
- 72" Gait Belt, Quick Release Buckle, Natural FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840216114036 FDA UDI
- FDA Product Code
- IKX FDA UDI
- GMDN Term
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical/medical face mask, non-antimicrobial, single-use
Primo by Asp Global, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/medical face mask, non-antimicrobial, single-use.
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- BENCO — BENCO DENTAL SUPPLY CO. · Class II
- Medicom AssureMask — AMD Medicom Inc · Class II
- Criterion — HENRY SCHEIN, INC. · Class II
- PRIMED — priMED Medical Products Inc · Class II
- NOVAPLUS — O&M HALYARD, INC. · Class II
- MEDICOM SAFEMASK CLASSICS — AMD Medicom Inc · Class II
- THE SEA — Mexpo International, 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 |
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Manufacturer
- Manufacturer
- Asp Global, LLC
Sources (1)
- FDA UDI 6b2f8e57-7ad6-403b-9ccc-ba5a04cee258 33 fields · synced May 31, 2026