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Standard rail universal holder

FDA UDI

Class II (US FDA UDI)

by Medela LLC

Identity

Trade Name
Standard rail universal holder FDA UDI
Generic Name
Suction/irrigation system canister/bottle holder, reusable FDA UDI
Device Name
Universal clamp with standard rail FDA UDI
Model / Reference
079.0040 FDA UDI
Description
Universal clamp with standard rail FDA UDI

Identifiers

Primary DI / UDI-DI
07612367038713 FDA UDI
510(k) Number
K141553 FDA UDI
K142626 FDA UDI
K172145 FDA UDI
FDA Product Code
BTA FDA UDI
OMP FDA UDI
GMDN Term
Suction/irrigation system canister/bottle holder, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 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 system canister/bottle holder, reusable

Standard rail universal holder by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suction/irrigation system canister/bottle holder, reusable.

Cleared under the same submission

K141553 also covers:

K142626 also covers:

K172145 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medela LLC

Sources (1)

  • FDA UDI 0ea9b3b9-7a7e-4535-8987-c4721000c127 35 fields · synced Jun 6, 2026