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Geri Water Bottle

FDA UDI

Class II (US FDA UDI)

by Genea Biomedx Pty Ltd

Identity

Trade Name
Geri Water Bottle FDA UDI
Generic Name
Intravenous/irrigation solution storage container, single-use FDA UDI
Device Name
The Geri Water Bottle is a two-piece (base and top) item, manufactured by injection molding in polystyrene material. FDA UDI
Model / Reference
GERI-WAT-01 FDA UDI
Description
The Geri Water Bottle is a two-piece (base and top) item, manufactured by injection molding in polystyrene material. FDA UDI

Identifiers

Primary DI / UDI-DI
09348265003048 FDA UDI
510(k) Number
K180304 FDA UDI
FDA Product Code
MQK FDA UDI
GMDN Term
Intravenous/irrigation solution storage container, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.6160 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intravenous/irrigation solution storage container, single-use

Geri Water Bottle by Genea Biomedx Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravenous/irrigation solution storage container, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genea Biomedx Pty Ltd

Sources (1)

  • FDA UDI 2b042c3b-18fd-44f4-a1ad-18968c6b29ee 34 fields · synced Jun 8, 2026