FDA.reportPublic FDA data

ClearCRIT® Plastic Capillary Tubes

Primary DI
00831829000281
Brand
ClearCRIT® Plastic Capillary Tubes
Company
SEPARATION TECHNOLOGY, INC.
Model
270-107
Catalog number
270-107
Published
2017-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GIOTube, Collection, Capillary Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00831829000281PrimaryGS10
00831829000298Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00831829000281008318290002818318290002810831829000281
00831829000298008318290002988318290002980831829000298

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection tube IVD, ammonium heparinA non-sterile glass or plastic collection tube containing the anticoagulant ammonium heparin, intended to be used for the collection preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device.

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
5
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
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
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

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