AccessGUDID - DEVICE: SP5555-POLE MOUNTING BRACKET (00886333621613)

GUDID

Device Identifier (DI) Information

Brand Name: SP5555-POLE MOUNTING BRACKET
Version or Model: 682161
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 682161
Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Primary DI Number: 00886333621613
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595138793 *Terms of Use

Device Description: holder

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
35504	Blood pressure transducer holder	A device used to secure a pressure transducer used for invasive blood pressure measurement at a desired height. The holder can be fastened to (e.g., a bed or an operating table) and can be adjusted so that the transducer is at the same level as the heart of the patient. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRB	Probe, Thermodilution

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: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 3d4b0234-5ebc-4d30-b492-a80dff8de700
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016