← Back to catalogue

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
CM-BT201 (MEDTRANS II) FDA UDI

Identifiers

Catalog Number
BL-0003-008 FDA UDI
Primary DI / UDI-DI
08888893501321 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bioptimal International Pte. Ltd.

Sources (1)

  • FDA UDI f3aa009e-1d5e-4df3-86ca-bca799fa2021 35 fields · synced May 30, 2026