Pulset™ 1cc Syringe

Basic Information

• Brand Name: Pulset™ 1cc Syringe
• Primary DI: 00709078012860
• Version / Model: 3105 MX
• Company Name: WESTMED, INC.
• Labeler DUNS: 092673953
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-04-28
• Public Version: 2
• Public Version Date: 2022-08-08
• Public Version Status: Update
• Public Device Record Key: 446fa9b7-9183-446d-8547-c58901d57766
• Distribution End Date: 2022-08-06

Device Description

Pulset™ 1cc Syringe, 25g c 5/8" (.5 x 15.9mm) Q-Cork, ~25u Balanced Heparin

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
Unit of Use	10709078012874	GS1
Primary	00709078012860	GS1