FDA.reportPublic FDA data

3D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)

Primary DI
00831829000458
Brand
3D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)
Company
SEPARATION TECHNOLOGY, INC.
Model
230-100D
Catalog number
230-100D
Published
2023-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00831829000441PrimaryGS10
00831829000458Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00831829000441008318290004418318290004410831829000441
00831829000458008318290004588318290004580831829000458

GMDN Terms#

Term, Definition table
TermDefinition
Centrifuge bucket/tube holder adaptorA device intended to compensate for and enable the use of different size test tubes and bottles in a centrifuge rotor bucket or centrifuge tube holder. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1800-531-5535info@ekfdiagnostics.com

Regulatory Flags#

DUNS number
195501127
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00831829000243Tube Sealant, Hemataseal260-100260-1002017-08-25
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
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
04050674030151Swing-out rotorAndreas Hettich GmbHGKG2021-09-02