J&J DePuy Synthes convenience kit

FDA UDI

Class II (US FDA UDI)

by Medela LLC

Identity

Trade Name: J&J DePuy Synthes convenience kit FDA UDI
Generic Name: Surgical suction pump FDA UDI
Device Name: Convenience kit containing: 1 x Dominant Flex Rack (item # 071.0003 ) with U.S. power cord 1 pack of Coupling Piece 90° (item # 077.1019, 10 pieces) 1 x IFU of each language region (EU 1, EU 2, Japan, Korea, China) FDA UDI
Model / Reference: 101043438 FDA UDI
Description: Convenience kit containing: 1 x Dominant Flex Rack (item # 071.0003 ) with U.S. power cord 1 pack of Coupling Piece 90° (item # 077.1019, 10 pieces) 1 x IFU of each language region (EU 1, EU 2, Japan, Korea, China) FDA UDI

Identifiers

Catalog Number: 101043438 FDA UDI
Primary DI / UDI-DI: 07612367080590 FDA UDI
FDA Product Code: BTA FDA UDI
HDB FDA UDI
MUU FDA UDI
QPB FDA UDI
GMDN Term: Surgical suction pump FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4780 FDA UDI
884.4340 FDA UDI
878.5040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Surgical suction pump

J&J DePuy Synthes convenience kit by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medela LLC

Sources (1)

FDA UDI ffaee3b1-037e-45c4-8d64-6d0d40e280e2 35 fields · synced Jun 8, 2026