← Back to catalogue

Thermodilution Catheter and Accessories

FDA UDI

Class II (US FDA UDI)

by Bioptimal International Pte. Ltd.

Identity

Trade Name
Thermodilution Catheter and Accessories FDA UDI
Generic Name
Pulmonary artery balloon catheter, non-electrical FDA UDI
Model / Reference
TD1702NX-ARG(497523) FDA UDI

Identifiers

Catalog Number
21-000119-01 FDA UDI
Primary DI / UDI-DI
08886483501300 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Pulmonary artery balloon catheter, non-electrical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Category: Pulmonary artery balloon catheter, non-electrical

Thermodilution Catheter and Accessories by Bioptimal International Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulmonary artery balloon catheter, non-electrical.

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 a16cd5d2-27a2-4af4-bc2e-41c0f5a9c72a 34 fields · synced Jun 1, 2026