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Maintenance Solution Kit Large

FDA UDI

Class I (US FDA UDI)

by Phadia GmbH

Identity

Trade Name
Maintenance Solution Kit Large FDA UDI
Generic Name
Plasma protein IVD, reagent FDA UDI
Device Name
Contains eight ampules of Maintenance Concentrate for use with Phadia instruments. FDA UDI
Model / Reference
10-9537-01 FDA UDI
Description
Contains eight ampules of Maintenance Concentrate for use with Phadia instruments. FDA UDI

Identifiers

Catalog Number
10-9537-01 FDA UDI
Primary DI / UDI-DI
07333066000985 FDA UDI
FDA Product Code
JJE FDA UDI
GMDN Term
Plasma protein IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2160 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Plasma protein IVD, reagent

Maintenance Solution Kit Large by Phadia GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Plasma protein IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phadia GmbH

Sources (1)

  • FDA UDI 89cfcae5-c909-4f55-b1c8-bed161aa3240 36 fields · synced May 30, 2026