SAFEDRAW(TM) DT-4812SDT

Basic Information

• Brand Name: SAFEDRAW(TM) DT-4812SDT
• Primary DI: 00886333621422
• Version / Model: 682142
• Catalog Number: 682142
• Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
• Labeler DUNS: 595138793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-06-11
• Public Version Status: Update
• Public Device Record Key: 9dcba8a2-9136-4b4c-bc16-dd872b8a12b5

Device Description

A 1-way 60 drops with 60" tube Adset connected to a 3cc transducer. The Safedraw is assembled with a 5cc restricted syringe stops at 2cc, with a 12" Pressure Tubing from the patient and a 48" Pressure tubing to the syringe. It also includes a separately packed 2x male protective caps and a Label Set.

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: 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
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35927	Invasive-pressure external transducer, single-use	A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50886333621427	GS1	Tyvek Bag	25	In Commercial Distribution
Primary	00886333621422	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3cc transducer, 60 drops Adset and 5cc syringe stops at 2cc