FDA.reportPublic FDA data

Fibrinotherm

Primary DI
05413760308371
Brand
Fibrinotherm
Company
BAXTER INTERNATIONAL INC.
Model
0600047
Catalog number
0600047
Device description
The FIBRINOTHERM Heating and Stirring Device is designed to facilitate the reconstitution of Baxter's two component Fibrin Sealant kit. The device consists of a heating block and an integrated magnetic stirrer.
Published
2018-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JRGBLOCK, HEATING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRGBlock, HeatingClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
55413760308376PackageGS11In Commercial Distribution
05413760308371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5541376030837655413760308376
05413760308371054137603083715413760308371

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory shakerAn electromechanical device, typically used in the laboratory or a blood bank, designed to shake/stir samples or mixtures with a rapid and forceful movement. It is used to provide a rapid mixing or to prevent substances comprised of different components from separation or sedimentation because of their different densities. It may be designed to secure single and/or multiple specimen containers (e.g., test tube, microplate) or specimen container holders during the shaking cycle; some types may have selectable agitation frequencies. It may also have a heating function to allow for temperature control of samples.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-0001MEDINFO_MEDPRODUCTS@BAXTER.COM

Regulatory Flags#

DUNS number
005146311
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412088303V-LINK/VITALSHIELD6N83996N83992016-09-24
00085412091785ONE-LINK7N83997N83992016-09-24
00085412087672LOW RECIRCULATION VOLUME APD SETN5C8305CN5C8305C2015-09-24
00085412088433AUTOMATED PD SETR5C4479CR5C4479C2015-09-24
00085412090078INTERGRATED APD SETL5C4531L5C45312015-09-24
00085412007021HomeChoice APD System5C44715C44712015-10-23
00085412007038HomeChoice APD System5C4471R5C4471R2015-10-23
00085412026350HomeChoice PRO APD System5C8310R5C8310R2015-10-23
00085412079165HomeChoice PRO APD System5C83105C83102015-10-23
00085412088341V-LINK/VITALSHIELD6N83786N83782016-09-24
00085412088327V-LINK/VITALSHIELD6N83746N83742016-09-24
00085412001036NA2C40312C40312016-09-24
00085412004716INTERLINK2N33332N33332016-09-24
00085412004921INTERLINK2N33762N33762016-09-24
00085412004976INTERLINK2N33952N33952016-09-24
00085412071657CLEARLINK2N83412N83412016-09-24
00085412001029NA2C40302C40302016-09-24
00085412003252N/A2B80662B80662016-09-24
00085412000046INTRAVIA2B80142B80142016-09-24
00085412003191INTRAVIA2B80122B80122016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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