FDA.reportPublic FDA data

CytoTherm

Primary DI
00861128000330
Brand
CytoTherm
Company
CYTOTHERM LP
Model
CT-D4
Device description
Plasma Thawing System
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
BK0600270

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0600270

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861128000330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861128000330008611280003308611280003300861128000330

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
057143901
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861128000309CytoThermCT-4S2016-09-01
00861128000316CytoThermCT-4T2016-09-01
00861128000323CytoThermCT-4T.6C2016-09-01
00861128000347CytoThermCT-DR2016-09-01
00861128000354CytoThermCT-D12016-09-01

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