FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NOVAPLUS
DI: 20888499012148
·
Model: VAT4437-XL
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- NOVAPLUS
- Primary DI
- 20888499012148
- Version / Model
- VAT4437-XL
- Catalog Number
- VAT4437-XL
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2019-11-07
- Public Version
- 3
- Public Version Date
- 2023-11-13
- Public Version Status
- Update
- Public Device Record Key
- a543a658-a6b6-4821-9e0e-523dbaf697ef
- Distribution End Date
- 2023-11-13
Device Description
Isolation Gown Yellow X-Large AAMI Level 2
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| OEA | Non-surgical isolation gown | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35405 | Blood transfusion set, exchange | A sterile, intravascular administration set used to remove a diseased infant's blood and replace it with fresh donor blood or plasma. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50888499012149 | GS1 | CASE | 10 | Not in Commercial Distribution | 2023-11-12 |
| Primary | 20888499012148 | GS1 | ||||
| Unit of Use | 10888499012141 | GS1 |