AccessGUDID - DEVICE: FifthPulse (00850026094855)

GUDID

Device Identifier (DI) Information

Brand Name: FifthPulse
Version or Model: Clear - L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FMN100047, TBN202954, TBN203042, TBN203058
Company Name: Jeg & Sons Inc.

Primary DI Number: 00850026094855
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 789973646 *Terms of Use

Device Description: Disposable Vinyl Exam Gloves

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":	No
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?
47176	Vinyl examination/treatment glove, non-powdered	A non-sterile device made of vinyl intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with talcum powder and it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYZ	Vinyl Patient Examination Glove

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: 6f0762cc-1b24-408f-b441-6bf8289d05ba
Public Version Date: December 26, 2022
Public Version Number: 1
DI Record Publish Date: December 16, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00850028714157	10	00850026094855	In Commercial Distribution	Carton/Case
00810084930236	2	00850028714157	In Commercial Distribution	Carton/Case
00810084930397	4	00810084930236	In Commercial Distribution	Carton/Case