| Primary Device ID | 00815947020475 |
| NIH Device Record Key | e9c70910-4334-4402-9330-35c44984ded6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cure Medical Catheter Insertion Kit |
| Version Model Number | K2 |
| Company DUNS | 070643426 |
| Company Name | CURE MEDICAL LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| Phone | 1-800-422-8811 |
| cic@convatec.com | |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815947020475 [Primary] |
| GS1 | 10815947020472 [Package] Package: Case [90 Units] In Commercial Distribution |
| GS1 | 20815947020479 [Package] Package: Case [100 Units] In Commercial Distribution |
| OHR | Catheter Care Tray |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2016-09-24 |
| 00815947020475 | Catheter Insertion Kit |
| 10815947020465 | Catheter Insertion Kit |