FDA.reportPublic FDA data

TrueCare Biomedix - USA

Primary DI
10850789007991
Brand
TrueCare Biomedix - USA
Company
U.S. Infusion, LLC
Model
TCBTEC-10R
Catalog number
TCBTEC-10R
Device description
TAMPER EVIDENT CAP, LUER LOCK CAP, RED, 10-PACK, 400 PCS/BOX
Published
2025-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
20850789007998PackageGS1400In Commercial Distribution
10850789007991PrimaryGS10
00850789007994Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085078900799820850789007998
1085078900799110850789007991
00850789007994008507890079948507890079940850789007994

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.

Contacts#

Phone, Email table
PhoneEmail
(305)593-8444info@tcbiomedix.com

Regulatory Flags#

DUNS number
005457284
Device count
10
Lot or batch
true
Expiration date on label
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
30850789007650TrueCare Biomedix TCBTECR-252021-10-13
10850789007373TrueCare BiomedixTCBINF2NFRB2020-01-30
10850789007380TrueCare BiomedixTCBPTTHBC012020-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01