FDA UDI
In Commercial Distribution
🇺🇸 United States
TrueCare Biomedix - USA
DI: 10199284146706
·
Model: TCBTEC-10B
·
U.S. Infusion, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- TrueCare Biomedix - USA
- Primary DI
- 10199284146706
- Version / Model
- TCBTEC-10B
- Catalog Number
- TCBTEC-10B
- Company Name
- U.S. Infusion, LLC
- Labeler DUNS
- 005457284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-09-09
- Public Version
- 1
- Public Version Date
- 2025-09-17
- Public Version Status
- New
- Public Device Record Key
- 1d8b21f5-dbc0-47f7-8e98-6a6fe3b77d46
Device Description
TAMPER EVIDENT CAP, LUER LOCK CAP, BLUE, 10-PACK, 400 PCS/BOX
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63614 | Luer-formatted protective cap | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20199284146703 | GS1 | Case | 400 | In Commercial Distribution | |
| Primary | 10199284146706 | GS1 | ||||
| Unit of Use | 00199284146709 | GS1 |
Customer Contacts
- Phone
- (305)593-8444
- [email protected]