AccessGUDID - DEVICE: ACCUTRANS™ Disposable Pressure Monitoring System (08886483503854)

GUDID

Device Identifier (DI) Information

Brand Name: ACCUTRANS™ Disposable Pressure Monitoring System
Version or Model: AT 4812-3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22-000942-03
Company Name: BIOPTIMAL INTERNATIONAL PTE. LTD.

Primary DI Number: 08886483503854
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595182247 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	No
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?
45275	Invasive blood pressure transducer set	A collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRS	Transducer, Blood-Pressure, Extravascular

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
Special Storage Condition, Specify: Store in dark cool dry places

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c2276bb-0dbc-490c-98e2-d398e609b6ad
Public Version Date: January 30, 2025
Public Version Number: 1
DI Record Publish Date: January 22, 2025