FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ASSURE® ID Insulin 1cc Safety Syringe
DI: 00015482102913
·
Model: 210291
·
ARKRAY USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ASSURE® ID Insulin 1cc Safety Syringe
- Primary DI
- 00015482102913
- Version / Model
- 210291
- Company Name
- ARKRAY USA, INC.
- Labeler DUNS
- 008171162
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2025-03-19
- Public Version Status
- Update
- Public Device Record Key
- 6e14eff8-fc0e-41a3-9e43-cc55594f2a38
- Distribution End Date
- 2025-03-18
Device Description
Sterile Safety Syringe
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMI | Needle, hypodermic, single lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45042 | Metered-delivery hypodermic syringe/needle | A sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10015482102910 | GS1 | Carton | 100 | Not in Commercial Distribution | 2025-03-18 |
| Primary | 00015482102913 | GS1 | ||||
| Package | 20015482102917 | GS1 | Master Shipper | 5 | Not in Commercial Distribution | 2025-03-18 |
Customer Contacts
- Phone
- +1(800)566-8558
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103011 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 29 | Gauge | |
| Length | 0.5 | Inch | |
| Total Volume | 1 | Milliliter |