AccessGUDID - DEVICE: SAFEDRAW(TM) DT-4812SDT (00886333621422)

GUDID

Device Identifier (DI) Information

Brand Name: SAFEDRAW(TM) DT-4812SDT
Version or Model: 682142
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 682142
Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Primary DI Number: 00886333621422
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595138793 *Terms of Use

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

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, Measurement, Blood-Pressure, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: 3cc transducer, 60 drops Adset and 5cc syringe stops at 2cc

Device Record Status

Public Device Record Key: 9dcba8a2-9136-4b4c-bc16-dd872b8a12b5
Public Version Date: June 11, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016