Device
BTR4812-3
Manufacturer
BIOPTIMAL INTERNATIONAL PTE. LTD.
Model: BTR4812-3 Catalog: 22-000813-23 DI: 08886483502390 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-04 Current Version: 2026-05-12
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 617fa236-9fde-43e8-bf55-1fc0e526a69b
Distribution Status: In Commercial Distribution
DUNS Number: 595182247
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 08886483502390
Type: Primary
Issuing Agency: GS1
GMDN
Code: 45275
Name: Invasive blood pressure transducer set
Definition:
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.
FDA Product Codes
DRS
Transducer, Blood-Pressure, Extravascular
Environmental Conditions
Storage Handling - Storage Handling Type: Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text: Store in dark cool dry places