FDA UDI
In Commercial Distribution
🇺🇸 United States
Droplet® insulin syringe
DI: 00859135002737
·
Model: 0.3ml, 30G x 12.7 mm
·
HTL STREFA S A
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- Droplet® insulin syringe
- Primary DI
- 00859135002737
- Version / Model
- 0.3ml, 30G x 12.7 mm
- Catalog Number
- 6227
- Company Name
- HTL STREFA S A
- Labeler DUNS
- 422528088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2025-02-20
- Public Version
- 1
- Public Version Date
- 2025-02-28
- Public Version Status
- New
- Public Device Record Key
- 0545e12c-728c-40aa-8e5a-54fc61bac41b
Device Description
droplet insulin syringes with fixed needles is a sterile single use syringe for the injection of U-100 insulin only
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
- 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 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 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 | 10859135002734 | GS1 | shipper box | 20 | In Commercial Distribution | |
| Primary | 00859135002737 | GS1 | ||||
| Unit of Use | 80859135002733 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201044 | 000 |