FDA.reportPublic FDA data

Tri-Tech Forensics, Inc.

Primary DI
00869373000204
Brand
Tri-Tech Forensics, Inc.
Company
TRI-TECH FORENSICS, INC.
Model
TUG10
Device description
10 ml Grey Stoppered Blood Tube, Each
Published
2020-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971111000TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPERTri-Tech, Inc.1997-06-16JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10869373000201PackageGS110In Commercial Distribution
20869373000208PackageGS110In Commercial Distribution
00869373000204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086937300020110869373000201
2086937300020820869373000208
00869373000204008693730002048693730002040869373000204

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated blood collection tube IVD, potassium oxalate/sodium fluorideA non-evacuated sterile glass or plastic tube, sealed with a stopper, containing the anticoagulant potassium oxalate and the antiglycolytic agent sodium fluoride. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Regulatory Flags#

DUNS number
105878292
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869373000211Tri-Tech Forensics, Inc.BA-2 DWI2020-02-25
00869373000259Tri-Tech Forensics, Inc.BA-0CO2020-02-25
10869373000201Tri-Tech Forensics, Inc.TUG102020-02-25
00869373000228Tri-Tech Forensics, Inc.BU-3 DWI2020-02-25
00869373000235Tri-Tech Forensics, Inc.UC-12020-02-25
00869373000242Tri-Tech Forensics, Inc.RE-1MS2020-02-25

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Primary DI, Brand, Company table
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