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BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables

FDA UDI

Class II (US FDA UDI)

by Bioptimal International Pte. Ltd.

Identity

Trade Name
BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables FDA UDI
Generic Name
Invasive-pressure external transducer, reusable FDA UDI
Model / Reference
BT-201 (BIOTRANS II STRUCTURAL PACK) FDA UDI

Identifiers

Catalog Number
BL-0003-013 FDA UDI
Primary DI / UDI-DI
08886483506961 FDA UDI
FDA Product Code
DRS FDA UDI
GMDN Term
Invasive-pressure external transducer, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Invasive-pressure external transducer, reusable

BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables by Bioptimal International Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Invasive-pressure external transducer, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioptimal International Pte. Ltd.

Sources (1)

  • FDA UDI 69c264f6-f018-4859-835c-2b5cab8c33e3 35 fields · synced May 31, 2026