Giraffe Incubator Carestation

GUDID 00840682116855

DATEX-OHMEDA INC

Conventional infant incubator
Primary Device ID00840682116855
NIH Device Record Key2276f2f4-82aa-4c97-8d88-795a6b45f9f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameGiraffe Incubator Carestation
Version Model NumberCS1
Company DUNS080887689
Company NameDATEX-OHMEDA INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682116855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMZINCUBATOR, NEONATAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-24

Devices Manufactured by DATEX-OHMEDA INC

00195278115171 - NOVII2024-06-11 NOVII+ POD
00195278212313 - NOVII2024-06-11 NOVII+ INTERFACE
00840682143677 - Giraffe In-Bed Scale2023-06-19 ASSY-LAU, GIRAFFE IN-BED SCALE, Finished good - Buy
00840682143721 - Panda In-Bed Scale2023-06-19 ASSY-LAU, PANDA IN-BED SCALE, Finished good - Buy
00840682145596 - Carestation 7502023-04-12 CARESTATION 750 A1
00840682146425 - Carestation 750c2023-04-12 CARESTATION 750c A1
00840682143684 - IV POLE ASSY 12 IN2022-12-14 IV POLE 12 IN
00840682143691 - ROTATING IV POLE2022-12-14 ROTATING IV POLE

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