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
OEA Non-surgical isolation gown

GMDN Terms

Code Name
35405 Blood transfusion set, exchange

Identifiers

Type ID
Package 50888499012149
Primary 20888499012148
Unit of Use 10888499012141