AccessGUDID - DEVICE: Pulset™ 3CC Syringe, A-Line, Blunt Tip w/protective sheath, 25 U BH (00709078003134)

GUDID

Device Identifier (DI) Information

Brand Name: Pulset™ 3CC Syringe, A-Line, Blunt Tip w/protective sheath, 25 U BH
Version or Model: 3300-31
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WESTMED, INC.

Primary DI Number: 00709078003134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 092673953 *Terms of Use

Device Description: Pulset™ 3CC Syringe, A-Line, Blunt Tip w/protective sheath, 25 U BH

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:	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?
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: 16879e0c-594c-4e0e-9652-0fd4530616d7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 06, 2017