FDA UDI
In Commercial Distribution
🇺🇸 United States
CDMA Quality Choice - Original Pen Needles
DI: 00635515959378
·
Model: AN 3529QC
·
CHAIN DRUG MARKETING ASSOCIATION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
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Basic Information
- Brand Name
- CDMA Quality Choice - Original Pen Needles
- Primary DI
- 00635515959378
- Version / Model
- AN 3529QC
- Catalog Number
- AN 3529QC
- Company Name
- CHAIN DRUG MARKETING ASSOCIATION, INC.
- Labeler DUNS
- 011920774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3234e23f-72d0-490e-b0fa-fcb59e65cf43
Device Description
For use with injectors for the subcutaneous injection of approved drugs, including insulin
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 | 00635515959378 | GS1 | ||||
| Unit of Use | 00384703529004 | GS1 | ||||
| Package | 00761059521334 | GS1 | Case | 50 | In Commercial Distribution | |
| Package | 00761059520337 | GS1 | Sleeve | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 248-449-9300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152339 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 12 | Millimeter | |
| Needle Gauge | 29 | Gauge |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius