FDA.reportPublic FDA data

TrueCare Biomedix

Primary DI
30850789007650
Brand
TrueCare Biomedix
Company
U.S. Infusion, LLC
Model
TCBTECR-25
Device description
Tamper Evident Cap
Published
2021-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40850789007657PackageGS1400In Commercial Distribution
30850789007650PrimaryGS10
00850789007659Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4085078900765740850789007657
3085078900765030850789007650
00850789007659008507890076598507890076590850789007659

GMDN Terms#

Term, Definition table
TermDefinition
Luer-formatted protective capA small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
305-593-8444akramarz@tcbiomedix.com

Regulatory Flags#

DUNS number
005457284
Device count
25
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850789007397TrueCare Biomedix TCBINFGSB122020-04-01
10850789007403TrueCare Biomedix TCBINF120SC2020-04-01
10850789007410TrueCare Biomedix TCBCOMBICAP2020-04-30
10850789007663TrueCare BiomedixTCBINF0422021-08-03
10850789007700TrueCare Biomedix TCBINF6481NC2022-12-31
10850789007717TrueCare Biomedix TCBEXT1.22022-12-31
10850789007724TrueCare Biomedix TCBEXT0.22022-12-31
10850789007748TrueCare BiomedixTCBEXTNF2023-10-01
10850789007755TrueCare Biomedix TCBEXTNF-E2023-10-01
10850789007816TrueCare Biomedix TCBINFSP12023-10-15
10850789007854TrueCare Biomedix TCBINF121SCTCBINF121SC2024-11-05
10850789007946TrueCare Biomedix TCBEXTNFBS-7TCBEXTNFBS-72024-11-05
10850789007953TrueCare Biomedix TCBEXTNFBM-7TCBEXTNFBM-72024-11-05
10850789007960TrueCare Biomedix TCBEXTNFBM-14TCBEXTNFBM-142024-11-05
20850789007394TrueCare Biomedix TCBINFGSB122020-04-01
20850789007400TrueCare Biomedix TCBINF120SC2020-04-01
20850789007417TrueCare Biomedix TCBCOMBICAP2020-04-30
10850789007373TrueCare BiomedixTCBINF2NFRB2020-01-30
10850789007380TrueCare BiomedixTCBPTTHBC012020-01-30
20850789007370TrueCare BiomedixTCBINF2NFRB2020-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840330704868ProCureTwin Med, LLCFMF2026-05-27
10840330704875ProCureTwin Med, LLCFMF2026-05-27
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08800052609310"Sure Fine Insulin Syringe 0.3cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609327"Sure Fine Insulin Syringe 0.3cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609334"Sure Fine Insulin Syringe 0.3cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609341"Sure Fine Insulin Syringe 0.5cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609358"Sure Fine Insulin Syringe 0.5cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609365"Sure Fine Insulin Syringe 0.5cc 30G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609372"Sure Fine Insulin Syringe 0.5cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609389"Sure Fine Insulin Syringe 1.0cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609396"Sure Fine Insulin Syringe 1.0cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609402"Sure Fine Insulin Syringe 1.0cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609419"Sure Fine Insulin Syringe 1.0cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609426"Sure Fine Insulin Syringe 0.3cc 31G x 1/4"""SHINA MED CORPORATIONFMF2026-03-25
08800052609433"Sure Fine Insulin Syringe 0.3cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609440"Sure Fine Insulin Syringe 0.3cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609457"Sure Fine Insulin Syringe 0.3cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609464"Sure Fine Insulin Syringe 0.5cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609471"Sure Fine Insulin Syringe 0.5cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609488"Sure Fine Insulin Syringe 0.5cc 30G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609495"Sure Fine Insulin Syringe 0.5cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609501"Sure Fine Insulin Syringe 1.0cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609518"Sure Fine Insulin Syringe 1.0cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609525"Sure Fine Insulin Syringe 1.0cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609532"Sure Fine Insulin Syringe 1.0cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08699207302028Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207305036Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207310030Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207311006Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17