Babytherm 8010 System

GUDID 04048675246558

Drägerwerk AG & Co. KGaA

Infant warmer
Primary Device ID04048675246558
NIH Device Record Key542bea9f-c7ff-45ca-89bd-ed4ad127aa07
Commercial Distribution Discontinuation2024-08-22
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBabytherm 8010 System
Version Model Number2M22380
Company DUNS315578914
Company NameDrägerwerk AG & Co. KGaA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com
Phone+494518820
Emailinfo@draeger.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104048675017097 [Primary]
GS104048675246558 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMTWarmer, Infant Radiant

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-23
Device Publish Date2015-10-24

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04048675035695 - Hook ring LITESTAR,15mm,conn.2024-10-10
04048675035701 - Hook ring LITESTAR,22mm,conn.2024-10-10
04048675246558 - Babytherm 8010 System2024-08-23
04048675246558 - Babytherm 8010 System2024-08-23
04048675703853 - HME HumidStar 2 Plus Luer-Lock2024-07-30
04048675540137 - Disposable Handle Polaris, Single2024-07-18

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