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Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K251663Ref 2082844-001

by Datex-Ohmeda Inc.

Identity

Trade Name
Giraffe Omnibed Carestation CS1 EUDAMED
Giraffe OmniBed Carestation FDA UDI
Generic Name
Conventional infant incubator FDA UDI
Device Name
GIRAFFE OMNIBED CARESTATION CS1 EUDAMEDFDA UDI
Model / Reference
2082844-001 EUDAMED
CS1 FDA UDI
Description
GIRAFFE OMNIBED CARESTATION CS1 FDA UDI

Identifiers

Primary DI / UDI-DI
00840682116862 EUDAMEDFDA UDI
Basic UDI-DI
8406821BUG00378HY EUDAMED
Direct Marketing DI
00840682116862 EUDAMED
510(k) Number
K251663 FDA 510(k)
K101788 FDA UDI
K152814 FDA UDI
K213551 FDA UDI
FDA Product Code
FMZ FDA 510(k)FDA UDI
FMT FDA UDI
EMDN Code
Z1208040302,Z12080407 EUDAMED
GMDN Term
Conventional infant incubator FDA UDI
Models / Variants
Giraffe OmniBed Carestation (CS1) FDA 510(k)FDA UDIEUDAMED
Giraffe Incubator Carestation (CS1) FDA 510(k)FDA UDIEUDAMED

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 880.5400 FDA 510(k)
Regulation Number
880.5400 FDA 510(k)FDA UDI
880.5130 FDA UDI
Market of Registration
France EUDAMED
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Giraffe OmniBed Carestation (CS1) is a neonatal incubator and warmer designed to provide a controlled microenvironment for infants. It functions as either an incubator or a radiant warmer, allowing transition between modes as clinically required, but not simultaneously in both configurations.

This device is intended for use in neonatal care settings, supplying sterile or non-sterile components depending on the application. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance and MDR authorisation. The system is supplied with specific model references and is regulated under the FDA’s General Hospital specialty category.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Giraffe Omnibed Carestation for Maternal Infant Care, Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1 ..., Giraffe Incubator Carestation for Maternal Infant Care, PDF Giraffe OmniBed Carestation CS1 - GE Healthcare

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Datex-Ohmeda Inc.
FDA Applicant
Datex-Ohmeda, Inc.

Sources (3)

  • FDA 510(k) K251663 24 fields · synced Oct 6, 2026
  • FDA UDI 97f38bdd-1d1c-4a24-a195-5f9ad6632b60 35 fields · synced May 30, 2026
  • EUDAMED b039d98e-455b-484d-9397-3683cf1d3f1f 61 fields · synced Jul 25, 2026