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Waveline EZ-MAX

FDA UDI

Class II (US FDA UDI)

by Avante

Identity

Trade Name
Waveline EZ-MAX FDA UDI
Generic Name
Patient monitoring system module, blood gas, transcutaneous FDA UDI
Model / Reference
60145T10ICO2 FDA UDI

Identifiers

Primary DI / UDI-DI
00815871021470 FDA UDI
510(k) Number
K131971 FDA UDI
FDA Product Code
DSI FDA UDI
CCK FDA UDI
CCL FDA UDI
DSK FDA UDI
DSA FDA UDI
MLD FDA UDI
FLL FDA UDI
CBR FDA UDI
CBQ FDA UDI
MHX FDA UDI
DXN FDA UDI
DRT FDA UDI
CBS FDA UDI
GMDN Term
Patient monitoring system module, blood gas, transcutaneous FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 FDA UDI
868.1400 FDA UDI
868.1720 FDA UDI
870.1110 FDA UDI
870.2900 FDA UDI
880.2910 FDA UDI
868.1700 FDA UDI
868.1500 FDA UDI
870.1130 FDA UDI
870.2300 FDA UDI
868.1620 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

Waveline EZ-MAX 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

K131971 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 87d6805b-d6b9-47d8-8834-5dcb30f0b47b 34 fields · synced May 30, 2026