AccessGUDID - DEVICE: CRITIFLO(TM) TAK1760M (00886333621286)

GUDID

Device Identifier (DI) Information

Brand Name: CRITIFLO(TM) TAK1760M
Version or Model: 682128
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 682128
Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Primary DI Number: 00886333621286
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595138793 *Terms of Use

Device Description: A separate 60 drops,60" tube Adset and a Critiflo flushing device connected to a 3-Way White OFF stopcock, Pressure tubing of length 48", 3-Way White OFF stopcock and 12" Pressure tubing. It also includes a separately packed 2x male protective caps.

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?
37257	Pressure transducer dome, single-use	A sterile plastic housing that connects together with an external pressure transducer (not included),, forming a measuring compartment. The transducer is influenced by the pressure of the medium, e.g., blood directly from a patient, that is channelled into the compartment, thereby creating the signals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXO	Transducer, Pressure, Catheter Tip

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: Adset is 60 drops, tube length 60"

Device Record Status

Public Device Record Key: 64d20120-9d02-4ea7-8f3d-71c021f3c284
Public Version Date: June 11, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016