AccessGUDID - DEVICE: NOVAPLUS (20888499012148)

GUDID

Device Identifier (DI) Information

Brand Name: NOVAPLUS
Version or Model: VAT4437-XL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: VAT4437-XL
Company Name: Cardinal Health 200, LLC

Primary DI Number: 20888499012148
Issuing Agency: GS1
Commercial Distribution End Date: November 13, 2023
Device Count: 10
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Isolation Gown Yellow X-Large AAMI Level 2

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OEA	Non-surgical isolation gown

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a543a658-a6b6-4821-9e0e-523dbaf697ef
Public Version Date: November 13, 2023
Public Version Number: 3
DI Record Publish Date: November 07, 2019