EC340L

GUDID 00851962007022

3.4 cu ft halo heat fluid warmer

ENTHERMICS, INC.

Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer
Primary Device ID00851962007022
NIH Device Record Key41c4c6ca-dc7d-4558-8e44-0a7a7293e3b9
Commercial Distribution Discontinuation2019-04-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEC340L
Version Model NumberEC340L
Company DUNS139782767
Company NameENTHERMICS, 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851962007022 [Primary]

FDA Product Code

LGZWarmer, Thermal, Infusion Fluid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-14
Device Publish Date2016-11-18

Devices Manufactured by ENTHERMICS, INC.

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00851962007619 - MED2422-L2021-06-04 2.5 cu ft zone heating fluid warmer
00851962007626 - MED2428-L2021-06-04 3.5 cu ft zone heating fluid warmer
00851962007633 - MED22262021-06-04 30" width single cavity zone heating blanket and fluid warmer, 18" depth
00851962007640 - MED29262021-06-04 30" width single cavity zone heating blanket and fluid warmer, 24" depth

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