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Echo CO2

FDA UDI

Class II (US FDA UDI)

by Avante

Identity

Trade Name
Echo CO2 FDA UDI
Generic Name
Patient monitoring system module, blood gas, transcutaneous FDA UDI
Model / Reference
60129MC FDA UDI

Identifiers

Primary DI / UDI-DI
00815871021340 FDA UDI
510(k) Number
K101539 FDA UDI
FDA Product Code
CCK FDA UDI
DQA FDA UDI
GMDN Term
Patient monitoring system module, blood gas, transcutaneous FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1400 FDA UDI
870.2700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose multi-parameter bedside monitorPatient monitoring system module, blood gas, transcutaneous

Echo CO2 by Avante — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, blood gas, transcutaneous.

Cleared under the same submission

K101539 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avante

Sources (1)

  • FDA UDI 8257f56b-550f-4a8c-b9d8-d03a7fba1f73 34 fields · synced Jun 1, 2026