FDA.reportPublic FDA data

plasmatherm

Primary DI
04059201000018
Brand
plasmatherm
Company
Barkey GmbH & Co. KG
Model
US-TCP
Catalog number
00000460
Device description
Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution
Published
2016-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZLDevice, Warming. Blood And Plasma

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZLDevice, Warming. Blood And PlasmaHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1000630

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1000630

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059201000018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059201000018040592010000184059201000018

GMDN Terms#

Term, Definition table
TermDefinition
Plasma thawing unitA mains electricity (AC-powered) device intended to be used to thaw, in a controlled manner, units of frozen plasma that have been stored, e.g., in the blood bank, prior to use. This device can use a number of methods to achieve this, e.g., microwave oven, heated water bath.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+12017081400info@genesisbps.com
+18662275393info@barkey-us.com

Regulatory Flags#

DUNS number
312555782
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059201002203Barkey S-line39 °C2022-06-13
04059201001701Barkey plasmatherm VUS-V000032962021-11-12
04059201001817Barkey plasmatherm C&GUS-C&G000034752021-11-12
04059201002135Barkey plasmatherm C&GUS-C&G 2.Gen000103402021-11-12
04059201000001plasmathermUS000004482016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20695085001826Level 1ICU MEDICAL, INC.KZL2026-01-08
10695085001829Level 1ICU MEDICAL, INC.KZL2026-01-08
04038917968560SAHARA-TSC 115VSarstedt Aktiengesellschaft & Co.KGKZL2023-11-24
00810144911137RediporAnalytiChem USA, Inc.KZL2023-09-21
04038917968324SAHARA-III basic model 115VSarstedt Aktiengesellschaft & Co.KGKZL2023-06-06
04038917968645SAHARA-III MAXITHERM 115VSarstedt Aktiengesellschaft & Co.KGKZL2023-06-06
04059201001701Barkey plasmatherm VBarkey GmbH & Co. KGKZL2021-11-12
04059201001817Barkey plasmatherm C&GBarkey GmbH & Co. KGKZL2021-11-12
04059201002135Barkey plasmatherm C&GBarkey GmbH & Co. KGKZL2021-11-12
07290115270006ZipThaw™ 202FREMON SCIENTIFIC, INC.KZL2020-03-06
20695085400100Level 1ICU MEDICAL, INC.KZL2019-09-25
30695085400107Level 1SMITHS MEDICAL MD, INC.KZL2019-09-25
50608223241108Bair Hugger™3M COMPANYKZL2017-01-30
35019315057919JelcoSmiths Medical ASD, Inc.KZL2017-01-03
20695085406003Level 1ICU MEDICAL, INC.KZL2016-10-14
20695085410017Level 1ICU MEDICAL, INC.KZL2016-10-14
20695085430008Level 1ICU MEDICAL, INC.KZL2016-10-14
20695085430015Level 1ICU MEDICAL, INC.KZL2016-10-14
30695085433006Level 1ICU MEDICAL, INC.KZL2016-10-14
40695085400302Level 1ICU MEDICAL, INC.KZL2016-10-14
40695085410004Level 1ICU MEDICAL, INC.KZL2016-10-14
10695085800217Level 1ICU MEDICAL, INC.KZL2016-10-14
10695085406006Level 1Smiths Medical ASD, Inc.KZL2016-10-14
20695085406010Level 1ICU MEDICAL, INC.KZL2016-10-14
50695085410018Level 1SMITHS MEDICAL MD, INC.KZL2016-10-14
10695085430001Level 1Smiths Medical ASD, Inc.KZL2016-10-14
50695085430016Level 1SMITHS MEDICAL MD, INC.KZL2016-10-14
10695085433002Level 1SMITHS MEDICAL MD, INC.KZL2016-10-14
30695085400305Level 1SMITHS MEDICAL MD, INC.KZL2016-10-14
10695085410003Level 1Smiths Medical ASD, Inc.KZL2016-10-14