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
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
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