FDA.reportPublic FDA data

UltraCrit Cleaning Tools

Primary DI
00831829000366
Brand
UltraCrit Cleaning Tools
Company
SEPARATION TECHNOLOGY, INC.
Model
320-113
Catalog number
320-113
Device description
UltraCrit Cleaning Tools are to be used to clean the UltraCrit and UltraCrit Plus devices.
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#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00831829000366PrimaryGS10
00831829000373Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00831829000366008318290003668318290003660831829000366
00831829000373008318290003738318290003730831829000373

GMDN Terms#

Term, Definition table
TermDefinition
Wash/cleaning solution IVD, manual equipmentA wash or cleaning solution intended to be used in the preparation, decontamination and/or cleanup of equipment (e.g., glassware, weighing equipment) used for the manual processing, staining and/or testing of clinical laboratory specimens.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
195501127
Device count
50
Kit
true
Lot or batch
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
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
00831829000137HemataChek, Low, Normal, High Control300-102300-1022017-08-25