FDA UDI
In Commercial Distribution
🇺🇸 United States
Assure® ID INSULIN SAFETY SYRINGE 0.5mL 31G x 6mm
DI: 00015482253158
·
Model: 253315
·
ARKRAY USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Assure® ID INSULIN SAFETY SYRINGE 0.5mL 31G x 6mm
- Primary DI
- 00015482253158
- Version / Model
- 253315
- Catalog Number
- N/A
- Company Name
- ARKRAY USA, INC.
- Labeler DUNS
- 008171162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-05-26
- Public Version
- 1
- Public Version Date
- 2020-06-03
- Public Version Status
- New
- Public Device Record Key
- 5cf1fc6d-e661-4442-bb27-5581f3de7f22
Device Description
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
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
- 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 |
|---|---|---|---|---|
| MEG | Syringe, Antistick | General Hospital | 880.5860 | 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 | 20015482253152 | GS1 | Master Carton | 8 | In Commercial Distribution | |
| Primary | 00015482253158 | GS1 | ||||
| Unit of Use | 50015482253153 | GS1 |
Customer Contacts
- Phone
- 1-800-818-8877
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132681 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 31 | Gauge | |
| Length | 6 | Millimeter | |
| Total Volume | 0.5 | Milliliter |