FDA.reportPublic FDA data

TRANSWAAG

Primary DI
04028339620139
Brand
TRANSWAAG
Company
Transmed Medizintechnik GmbH & Co. KG
Model
TRANSWAAG PRO
Catalog number
97.8700.105
Device description
Blood mixing and weighing device
Published
2020-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KSQDevice, Blood Mixing And Blood Weighing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSQDevice, Blood Mixing And Blood WeighingHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0300060

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0300060

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04028339620139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04028339620139040283396201394028339620139

GMDN Terms#

Term, Definition table
TermDefinition
Blood weighing scaleA mains electricity (AC-powered), electronic device specially designed to provide the precise weight of blood.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
320762776
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04028339720235SAHARASAHARA-TSC 115V97.8710.6022016-08-15
04028339710236SAHARASAHARA-III basic model 115V97.8710.5022016-08-15
04028339710939SAHARASAHARA-III MAXITHERM 115V97.8710.8022016-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00866305000288Genesis Tube StripperGENESIS BPS LLCKSQ2025-01-31
04086000860888COMPOGUARD Advance BasicFresenius Kabi AGKSQ2024-10-30
04086000860895COMPOGUARD Advance DataFresenius Kabi AGKSQ2024-10-29
04086000860901COMPOGUARD Advance COMPLETEFresenius Kabi AGKSQ2024-10-29
00850047037077HemoFlowApplied Science, Inc.KSQ2024-03-11
00850047037084HemoFlowApplied Science, Inc.KSQ2024-03-11
00850047037053HemoFlowApplied Science, Inc.KSQ2023-09-08
00863626000270Boekel Blood Collection MixerBOEKEL INDUSTRIES, INC.KSQ2023-06-08
00850047037022HemoFlowApplied Science, Inc.KSQ2023-03-14
00850047037039HemoFlowApplied Science, Inc.KSQ2023-03-03
00850047037046HemoFlowApplied Science, Inc.KSQ2023-03-03
00850047037008HemoFlowApplied Science, Inc.KSQ2023-02-21
00850047037015HemoFlowApplied Science, Inc.KSQ2023-02-21
04038917141154Tube- Stripper AST-2Sarstedt Aktiengesellschaft & Co.KGKSQ2022-11-30
04038917258869Tube-Stripper AST-2SSarstedt Aktiengesellschaft & Co.KGKSQ2022-11-30
04086000860741CompoGuard Basic (NA)Fresenius Kabi AGKSQ2022-11-10
04086000860758CompoGuard Data (NA)Fresenius Kabi AGKSQ2022-11-10
04086000860765CompoGuard Complete (NA)Fresenius Kabi AGKSQ2022-11-10
00810020440065Donor Tube StripperFresenius Kabi AGKSQ2022-11-04
00810020440348Fresenius Kabi Adjustable Automatic Donor Scale Support StandFresenius Kabi AGKSQ2021-08-18
10810020440345Fresenius Kabi Adjustable Automatic Donor Scale Support StandFresenius Kabi AGKSQ2021-08-18
08809241446224Blood Collection Monitor CM350CENTRON CORPORATIONKSQ2020-04-17
08809241446132Blood Collection Mixer CM735ACENTRON CORPORATIONKSQ2020-04-03
08809241446446Data Collection Mixer DCM3000 (BASIC)CENTRON CORPORATIONKSQ2020-04-03
00863626000218Boekel Small Platelet AgitatorBOEKEL INDUSTRIES, INC.KSQ2019-05-16
00816394020971HelmerHELMER, INC.KSQ2019-02-08
00816394020988HelmerHELMER, INC.KSQ2019-02-08
00816394020995HelmerHELMER, INC.KSQ2019-02-08
00863626000225Boekel Large Platelet AgitatorBOEKEL INDUSTRIES, INC.KSQ2017-01-31
00816394020797i.Series® HELMER, INC.KSQ2016-07-01