Identity
- Trade Name
- Beesure FDA UDI
- Generic Name
- Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
- Device Name
- Beesure Pure Vibe ASTM 3 Face Mask 50 /BX , White FDA UDI
- Model / Reference
- BE2580 FDA UDI
- Description
- Beesure Pure Vibe ASTM 3 Face Mask 50 /BX , White FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10817508023151 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Surgical/medical respirator, non-antimicrobial, single-use 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical/medical respirator, non-antimicrobial, single-use
Beesure by Ascend Eagle Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical/medical respirator, non-antimicrobial, single-use.
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- 3M — 3M COMPANY · Class II
- Zhou Medical N95 Respirator Mask — ZHOU MEDICAL SOLUTIONS LLC · 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
- Ascend Eagle Incorporated
Sources (1)
- FDA UDI 65e40dcd-85f7-4cb8-9891-35884b337032 34 fields · synced May 31, 2026