AccessGUDID - DEVICE: Pulset (00709078007408)

GUDID

Device Identifier (DI) Information

Brand Name: Pulset
Version or Model: 3165-95
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WESTMED, INC.

Primary DI Number: 00709078007408
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 092673953 *Terms of Use

Device Description: Modified Kit, Pulset 1cc Syringe 25g x 5/8" (.5 x 15.9mm) Crickett 25u Balanced Heparin

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
31336	Arterial blood sampling kit	A collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBT	Arterial Blood Sampling Kit

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: Yes
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: 341e5ad5-cd16-4660-9269-8431639420c9
Public Version Date: September 30, 2022
Public Version Number: 3
DI Record Publish Date: July 31, 2019