AccessGUDID - DEVICE: VIVIT Supply (10810141931401)

GUDID

Device Identifier (DI) Information

Brand Name: VIVIT Supply
Version or Model: 20121
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Vivit Supply LLC

Primary DI Number: 10810141931401
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 300
Labeler D-U-N-S® Number*: 119042597 *Terms of Use

Device Description: Commend Nitrile Exam Glove, Chemo Drug Tested, Textured Fingertips, Powder-Free,

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):	No
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?
66499	Total immunoglobulin E (IgE total) IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total immunoglobulin E (IgE total) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZA	Polymer Patient Examination Glove

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Store in cool, dry, and well ventilated space out of direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b7ddd3ee-6f4d-4b8c-9cfd-cf03457d4e9d
Public Version Date: April 03, 2024
Public Version Number: 1
DI Record Publish Date: March 26, 2024