FDA UDI
In Commercial Distribution
🇺🇸 United States
Clever Choice Comfort EZ
DI: 00898302001982
·
Model: Insulin Pen 31G 5/16"
·
SIMPLE DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Clever Choice Comfort EZ
- Primary DI
- 00898302001982
- Version / Model
- Insulin Pen 31G 5/16"
- Catalog Number
- 98302-0001-98
- Company Name
- SIMPLE DIAGNOSTICS INC
- Labeler DUNS
- 004135503
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-08-08
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 0f9a8242-6b8c-46cc-b305-8b282e912532
Device Description
Insulin Pen Needle 5/16 inch length and 31 gauge
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00898302001982 | GS1 | ||||
| Package | 10898302001989 | GS1 | Case | 30 | In Commercial Distribution | |
| Unit of Use | 20898302001986 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Millimeter | |
| Needle Gauge | 31 | Gauge |