FDA UDI
In Commercial Distribution
🇺🇸 United States
VIVIT Supply
DI: 10810141933702
·
Model: 2225CO
·
Vivit Supply LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- VIVIT Supply
- Primary DI
- 10810141933702
- Version / Model
- 2225CO
- Company Name
- Vivit Supply LLC
- Labeler DUNS
- 119042597
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2025-09-18
- Public Version
- 1
- Public Version Date
- 2025-09-26
- Public Version Status
- New
- Public Device Record Key
- b2ac1a85-97c6-4b0e-976f-397c127060ba
Device Description
Coverall, Elastic Cuff, Traditional Collar, White, XL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65414 | Surgical coverall | A single-piece, fluid-resistant garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, legs, and head during a surgical procedure or for other appropriate medical reasons. Also known as a jump suit, it is used to help protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material; it may include separate shoe covers. This is a single-use garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20810141933709 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 10810141933702 | GS1 | ||||
| Unit of Use | 00810141933705 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry, and well ventilated space out of direct sunlight.