Identity
- Trade Name
- VIVIT Supply FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- Overhead AAMI 4 Open Back Gown, Knit Cuff, Blue, Universal FDA UDI
- Model / Reference
- 436B FDA UDI
- Description
- Overhead AAMI 4 Open Back Gown, Knit Cuff, Blue, Universal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810141933337 FDA UDI
- FDA Product Code
- FYA FDA UDI
- GMDN Term
- Surgical gown, single-use 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical gown, single-use
VIVIT Supply by Vivit Supply LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical gown, single-use.
- Halyard — O&M HALYARD, INC. · Class II
- Yellow gown with elastics (length 120 cm) — Omnia Spa · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Beaver Visitec Inter — GRI Medical & Electronic Technology Co., Ltd. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- T7 — Stryker Corp. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vivit Supply LLC
Sources (1)
- FDA UDI b6679e92-4f6d-4832-8201-ed2754d067ed 34 fields · synced Jun 8, 2026