AccessGUDID - DEVICE: BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables (08886483508330)

GUDID

Device Identifier (DI) Information

Brand Name: BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables
Version or Model: BT-201 (CAT#5867983)-GE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BL-0003-021
Company Name: BIOPTIMAL INTERNATIONAL PTE. LTD.

Primary DI Number: 08886483508330
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?
14119	Invasive-pressure external transducer, reusable	A 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 reusable 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: 70061945-5570-49cf-8d2a-3b7647ee24dc
Public Version Date: March 31, 2021
Public Version Number: 1
DI Record Publish Date: March 23, 2021