Safedraw™

Basic Information

• Brand Name: Safedraw™
• Primary DI: 10884450327668
• Version / Model: 10884450327668
• Catalog Number: 689361/A
• Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
• Labeler DUNS: 595138793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-02-09
• Public Version: 4
• Public Version Date: 2021-12-13
• Public Version Status: Update
• Public Device Record Key: 6f4fe78b-8e2f-44be-80d9-2f9ff872c92b

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
DSK	COMPUTER, BLOOD-PRESSURE	Cardiovascular	870.1110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45760	In-line arterial blood sampling set	A collection of sterile devices designed to obtain an in-line arterial blood specimen while maintaining a closed system. It is a haemodynamic pressure monitoring and blood gas sampling device, typically designed for use with disposable/reusable pressure transducers, intended to connect to a central line/arterial catheter from which the blood specimen is obtained. Heparinized blood may be reinfused into the patient via the device to reduce fluid loss. This is a single-patient device that may be used short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884450327665	GS1		5	In Commercial Distribution
Primary	10884450327668	GS1
Unit of Use	00884450327661	GS1