| Primary Device ID | 00635515959378 |
| NIH Device Record Key | 3234e23f-72d0-490e-b0fa-fcb59e65cf43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CDMA Quality Choice - Original Pen Needles |
| Version Model Number | AN 3529QC |
| Catalog Number | AN 3529QC |
| Company DUNS | 011920774 |
| Company Name | CHAIN DRUG MARKETING ASSOCIATION, INC. |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Phone | 248-449-9300 |
| xx@xx.xx | |
| Phone | 248-449-9300 |
| xx@xx.xx |
| Needle Gauge | 29 Gauge |
| Needle Gauge | 29 Gauge |
| Needle Gauge | 29 Gauge |
| Needle Gauge | 29 Gauge |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384703529004 [Unit of Use] |
| GS1 | 00635515959378 [Primary] |
| GS1 | 00761059520337 [Package] Package: Sleeve [10 Units] In Commercial Distribution |
| GS1 | 00761059521334 [Package] Contains: 00761059520337 Package: Case [50 Units] In Commercial Distribution |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-19 |
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