FDA UDI
In Commercial Distribution
🇺🇸 United States
US DIAGNOSTICS Pen Needles, 31G x 6MM, 50ea
DI: 00857513006377
·
Model: 100099
·
YIDOBIO Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
Basic Information
- Brand Name
- US DIAGNOSTICS Pen Needles, 31G x 6MM, 50ea
- Primary DI
- 00857513006377
- Version / Model
- 100099
- Company Name
- YIDOBIO Inc.
- Labeler DUNS
- 689512763
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2018-05-24
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 44add180-be1f-4aa9-9e0b-0b800a8d6973
Device Description
US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major brands of injection pens. This needle is a device for subcutaneous injection of medicines used for pen type of insulin syringe as subcutaneous injectables.
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 |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44127 | Autoinjector needle | A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20857513006371 | GS1 | Outer Box | 5 | In Commercial Distribution | |
| Package | 10857513006374 | GS1 | Middle Box | 20 | In Commercial Distribution | |
| Primary | 00857513006377 | GS1 | ||||
| Unit of Use | 90857513006370 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160575 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 31 | Gauge | |
| Length | 6 | Millimeter |