FDA.reportPublic FDA data

Tube Sealant, Hemataseal

Primary DI
00831829000243
Brand
Tube Sealant, Hemataseal
Company
SEPARATION TECHNOLOGY, INC.
Model
260-100
Catalog number
260-100
Published
2017-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKGCentrifuge, Hematocrit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKGCentrifuge, HematocritHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00831829000243PrimaryGS10
00831829000250Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00831829000243008318290002438318290002430831829000243
00831829000250008318290002508318290002500831829000250

GMDN Terms#

Term, Definition table
TermDefinition
Microhaematocrit centrifugeA tabletop- or bench-mounted mains electricity (AC-powered) device used mainly in the clinical laboratory to process through high-speed centrifugal force (typically 10,000 to 25,000 rpm) specimens of whole blood to determine the ratio of the red cell volume to the whole blood volume expressed as a decimal, fraction, or percentage. The device typically generates a relative centrifugal force (RCF) of at least 10,000 x g to efficiently pack cells in a short time (i.e., 3 to 5 minutes) and requires a smaller sample size than low-speed conventional centrifuges (macrohaematocrit method). The haematocrit is typically used to diagnose blood loss and erythrocyte count above or below normal.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
195501127
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008318290004413D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)230-100D230-100D2023-11-06
008318290004583D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)230-100D230-100D2023-11-06
00831829000427UltraCrit Loaner100-201100-2012023-03-01
00831829000014UltraCrit100-200100-2002017-08-25
00831829000045UltraCrit QC Cuvettes 270-112270-1122017-08-25
00831829000069UltraChek Reference Controls Low 300-116300-1162017-08-25
00831829000083UltraChek Reference Controls Normal300-117300-1172017-08-25
00831829000106UltraChek Reference Controls High300-118300-1182017-08-25
00831829000380UltraCrit (Refurbished)R100-200R100-2002017-09-28
00831829000410HemataSTAT II Centrifuge 100-133100-1332022-03-31
00831829000120HemataSTAT II Centrifuge 100-100100-1002017-08-25
00831829000397HemataSTAT II Centrifuge (Refurbished)R100-100R100-1002018-04-17
00831829000021UltraCrit Cuvettes 270-111270-1112017-08-25
00831829000267ClearCRIT® Plastic Capillary Tubes270-106270-1062017-08-25
00831829000281ClearCRIT® Plastic Capillary Tubes270-107270-1072017-08-25
00831829000304ClearCrit Mylar®Coated Glass Capillary Tubes 270-108270-1082017-08-25
00831829000328ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes 270-109270-1092017-08-25
00831829000403ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes 270-109VL270-109VL2017-12-14
00831829000366UltraCrit Cleaning Tools 320-113320-1132017-08-25
00831829000137HemataChek, Low, Normal, High Control300-102300-1022017-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008318290004413D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)SEPARATION TECHNOLOGY, INC.GKG2023-11-06
008318290004583D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)SEPARATION TECHNOLOGY, INC.GKG2023-11-06
00840095655699Globe ScientificGLOBE SCIENTIFIC INC.GKG2023-07-05
00664816005651LW Scientific, Inc.LW SCIENTIFIC, INC.GKG2023-01-30
00664816005668LW Scientific, Inc.LW SCIENTIFIC, INC.GKG2023-01-30
00664816005309LW Scientific, Inc.LW SCIENTIFIC, INC.GKG2022-10-25
00664816005576LW Scientific, Inc.LW SCIENTIFIC, INC.GKG2022-09-09
00664816005613LW Scientific, Inc.LW SCIENTIFIC, INC.GKG2022-09-09
40612479200102McKessonMCKESSON MEDICAL-SURGICAL INC.GKG2022-08-31
00304040043370Henry ScheinHENRY SCHEIN, INC.GKG2022-05-03
00831829000410HemataSTAT II Centrifuge SEPARATION TECHNOLOGY, INC.GKG2022-03-31
04050674026284BucketAndreas Hettich GmbHGKG2021-09-03
04050674026338BucketAndreas Hettich GmbHGKG2021-09-03
04050674026345BucketAndreas Hettich GmbHGKG2021-09-03
04050674026383BucketAndreas Hettich GmbHGKG2021-09-03
04050674026772BucketAndreas Hettich GmbHGKG2021-09-03
04050674068369BucketAndreas Hettich GmbHGKG2021-09-03
04050674077149BucketAndreas Hettich GmbHGKG2021-09-03
04050674078856BucketAndreas Hettich GmbHGKG2021-09-03
04050674079037BucketAndreas Hettich GmbHGKG2021-09-03
04050674082839BucketAndreas Hettich GmbHGKG2021-09-03
04050674092487BucketAndreas Hettich GmbHGKG2021-09-03
04050674092494BucketAndreas Hettich GmbHGKG2021-09-03
04050674027663Angle rotorAndreas Hettich GmbHGKG2021-09-02
04050674027748Angle rotorAndreas Hettich GmbHGKG2021-09-02
04050674027830Angle rotorAndreas Hettich GmbHGKG2021-09-02
04050674027854Angle rotorAndreas Hettich GmbHGKG2021-09-02
04050674028318Angle rotorAndreas Hettich GmbHGKG2021-09-02
04050674028325Angle rotorAndreas Hettich GmbHGKG2021-09-02
04050674030076Swing-out rotorAndreas Hettich GmbHGKG2021-09-02