| Primary Device ID | 20887787006692 |
| NIH Device Record Key | cae3f19e-af36-4815-93c0-de41d59e733f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Irrigation Set |
| Version Model Number | 653665 |
| Catalog Number | 0653665 |
| Company DUNS | 830767898 |
| Company Name | ICU MEDICAL FLEET SERVICES, 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 | 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 | false |
| Phone | +1(877)946-7747 |
| uscustomercare@icumed.com |
| Device Size Text, specify | 0 |
| Length | 70 Inch |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10887787006695 [Primary] |
| GS1 | 20887787006692 [Package] Contains: 10887787006695 Package: case [20 Units] In Commercial Distribution |
| HIBCC | M3356536650 [Secondary] |
| GBX | CATHETER, IRRIGATION |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-30 |
| Device Publish Date | 2018-06-28 |
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