FDA.reportPublic FDA data

Tri-Tech Forensics, Inc.

Primary DI
00869373000211
Brand
Tri-Tech Forensics, Inc.
Company
TRI-TECH FORENSICS, INC.
Model
BA-2 DWI
Device description
Tri-Tech Forensics Custom Blood Alcohol Kit
Published
2020-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
K922342000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922342000TRI-TECH INC. CUSTOM BLOOD ALCOHOLTri-Tech, Inc.1993-08-27JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869373000211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869373000211008693730002118693730002110869373000211

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of sterile devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height2.5Inch
Length5Inch
Width3.75Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869373000259Tri-Tech Forensics, Inc.BA-0CO2020-02-25
00869373000204Tri-Tech Forensics, Inc.TUG102020-02-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08586015044823CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
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10850074089091SurgycoSurgyco LLCJKA2025-12-23
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10850074089114SurgycoSurgyco LLCJKA2025-12-23
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