FDA UDI
In Commercial Distribution
🇺🇸 United States
Ultra-Fine
DI: 00383017846817
·
Model: 328468
·
Embecta Medical II, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
Basic Information
- Brand Name
- Ultra-Fine
- Primary DI
- 00383017846817
- Version / Model
- 328468
- Catalog Number
- 328468
- Company Name
- Embecta Medical II, LLC
- Labeler DUNS
- 118777356
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-11-22
- Public Version
- 1
- Public Version Date
- 2024-12-02
- Public Version Status
- New
- Public Device Record Key
- f5bcdcbd-26a5-4971-b143-3939ad857ee2
Device Description
Ultra-Fine™ Insulin Syringes, U-100, 8mm, 31G, 0.5mL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- 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 | 00383017846831 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 00383017846817 | GS1 | ||||
| Package | 50383017846850 | GS1 | Case | 5 | In Commercial Distribution | |
| Unit of Use | 80383017846882 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 31 | Gauge | |
| Length | 8 | Millimeter |