Pulset

Basic Information

• Brand Name: Pulset
• Primary DI: 00709078009129
• Version / Model: 3393
• Company Name: WESTMED, INC.
• Labeler DUNS: 092673953
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 3
• Public Version Date: 2022-09-30
• Public Version Status: Update
• Public Device Record Key: eb8641aa-54d3-49b6-925c-f021414fde0d
• Distribution End Date: 2022-09-30

Device Description

Full Kit, Pulset 3cc Syringe 23g x 1" (.6 x 25mm) Q-Cork 25u Balanced Heparin

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBT	Arterial Blood Sampling Kit	Anesthesiology	868.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10709078009126	GS1		100	Not in Commercial Distribution	2022-09-30
Primary	00709078009129	GS1