Identity
- Trade Name
- Shoe cover (33gsm PP full elastic) [EMS-10211] FDA UDI
- Generic Name
- Shoe cover FDA UDI
- Model / Reference
- EMS-10211 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20376885024016 FDA UDI
- FDA Product Code
- FXP FDA UDI
- GMDN Term
- Shoe cover 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Shoe cover
Shoe cover (33gsm PP full elastic) [EMS-10211] by Emergency Medical Solutions LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Shoe cover.
- Halyard — O&M HALYARD, INC. · Class I
- Halyard — O&M HALYARD, INC. · Class I
- Critical Cover — ALPHAPROTECH, INC. · Class I
- PremierPro — SVS LLC · Class I
- Critical Cover — ALPHAPROTECH, INC. · Class I
- Critical Cover — ALPHAPROTECH, INC. · Class I
- PRO ADVANTAGE — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Emergency Medical Solutions LLC
Sources (1)
- FDA UDI d6b89d6b-546e-43a1-8223-250e19657000 32 fields · synced May 30, 2026