Identity
- Trade Name
- NOVO Health Services, LLC FDA UDI
- Generic Name
- Isolation gown, reusable FDA UDI
- Device Name
- Gown, L2 M, 5-Pack NS FDA UDI
- Model / Reference
- 8002 FDA UDI
- Description
- Gown, L2 M, 5-Pack NS FDA UDI
Identifiers
- Catalog Number
- 8002D FDA UDI
- Primary DI / UDI-DI
- 00812564039866 FDA UDI
- FDA Product Code
- FYA FDA UDI
- GMDN Term
- Isolation gown, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 4.3 Pound FDA UDIWidth — 10 Inch FDA UDIHeight — 4.5 Inch FDA UDI
Category: Isolation gown, reusable
NOVO Health Services, LLC by Novo Health Services, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Isolation gown, reusable.
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Generic Polyester Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- ComPel Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- HENRY SCHEIN — HENRY SCHEIN, INC. · Class II
- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- AQUIST WASHABLE ISOLATION GOWN — MAXILL, INC. · Class I
Cleared under the same submission
K003755 also covers:
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
K090383 also covers:
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novo Health Services, Llc
Sources (1)
- FDA UDI c83c7948-d7d1-4f28-ae85-89b084a33dcb 37 fields · synced May 30, 2026