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Change over valve

FDA UDI

Class II (US FDA UDI)

by Medela LLC

Identity

Trade Name
Change over valve FDA UDI
Generic Name
Suction/irrigation tubing, reusable FDA UDI
Device Name
Change over valve FDA UDI
Model / Reference
077.0561 FDA UDI
Description
Change over valve FDA UDI

Identifiers

Primary DI / UDI-DI
07612367003575 FDA UDI
FDA Product Code
HDB FDA UDI
BTA FDA UDI
GCX FDA UDI
QPB FDA UDI
GMDN Term
Suction/irrigation tubing, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4340 FDA UDI
878.4780 FDA UDI
880.6740 FDA UDI
878.5040 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Suction/irrigation tubing, reusable

Change over valve by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suction/irrigation tubing, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medela LLC

Sources (1)

  • FDA UDI b6dfb74c-83e9-415a-9cc8-7fb5e30acdc0 34 fields · synced Jun 8, 2026