FDA.reportPublic FDA data

Tri-Tech Forensics, Inc.

Primary DI
10869373000201
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
Rx
false
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
105878292
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00869373000211Tri-Tech Forensics, Inc.BA-2 DWI2020-02-25
00869373000259Tri-Tech Forensics, Inc.BA-0CO2020-02-25
00869373000204Tri-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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