FDA UDI
In Commercial Distribution
🇺🇸 United States
TRUEplus
DI: 00021292005795
·
Model: TRUEplus SINGLE-USE INSULIN syringes 28 gauge needle 1.0cc insulin
·
TRIVIDIA HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
10
Pkg Device Count
10
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Basic Information
- Brand Name
- TRUEplus
- Primary DI
- 00021292005795
- Version / Model
- TRUEplus SINGLE-USE INSULIN syringes 28 gauge needle 1.0cc insulin
- Company Name
- TRIVIDIA HEALTH, INC.
- Labeler DUNS
- 151810868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d0ec1c03-2a44-4e15-ac42-9344b2319c47
Device Description
TRUEplus SINGLE-USE INSULIN syringes 28 gauge needle 1.0cc insulin
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| 38501 | Insulin syringe/needle, basic | A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50096295125349 | GS1 | Case | 8 | In Commercial Distribution | |
| Package | 00096295125344 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00021292005795 | GS1 | ||||
| Package | 10087701426084 | GS1 | Case | 8 | In Commercial Distribution | |
| Package | 00087701426087 | GS1 | Box | 10 | In Commercial Distribution | |
| Package | 10021292007291 | GS1 | Case | 8 | Not in Commercial Distribution | 2018-04-16 |
| Package | 00021292007294 | GS1 | Box | 10 | Not in Commercial Distribution | 2018-04-16 |
| Package | 10021292004962 | GS1 | Case | 8 | In Commercial Distribution | |
| Package | 00021292004965 | GS1 | Box | 10 | In Commercial Distribution | |
| Unit of Use | 00021292008031 | GS1 |
Customer Contacts
- Phone
- +1(800)803-6025
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K993017 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 0.50 | Inch | |
| Total Volume | 1.0 | Milliliter | |
| Needle Gauge | 28 | Gauge |