Carpediem

FDA UDI

Class II (US FDA UDI)

by Mozarc Medical US LLC

Identity

Trade Name: CARPEDIEM FDA UDI
Generic Name: Haemodialysis system, institutional FDA UDI
Device Name: CARPEDIEM FDA UDI
Model / Reference: IB7010250 FDA UDI
Description: CARPEDIEM FDA UDI

Identifiers

Primary DI / UDI-DI: 08051736003652 FDA UDI
510(k) Number: DEN180055 FDA UDI
FDA Product Code: QIR FDA UDI
GMDN Term: Haemodialysis system, institutional FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5861 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 118 Centimeter FDA UDI
Width — 57 Centimeter FDA UDI
Height — 67 Centimeter FDA UDI
Weight — 40 Gram FDA UDI

Category: Haemodialysis system, institutional

Carpediem by Mozarc Medical US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis system, institutional.

B.BRAUN — B.Braun Avitum AG · Class I
Prismaflex — Gambro, Inc. · Class II
2008® Series Hemodialysis Machines — Fresenius Usa, Inc. · Class II
B.BRAUN — B.Braun Avitum AG · Class II
Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II

Cleared under the same submission

DEN180055 also covers:

CARPEDIEM — Mozarc Medical US LLC
CARPEDIEM — Mozarc Medical US LLC

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: Mozarc Medical US LLC

Sources (1)

FDA UDI b853adf0-542c-47c3-b457-24cc18c4ff2f 37 fields · synced Jun 8, 2026