| Primary Device ID | 20811870034125 |
| NIH Device Record Key | 4856242f-e691-4865-9827-b1cdec51cfe3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Custom Healthcare Systems Inc. |
| Version Model Number | CDWS-18374B |
| Company DUNS | 175254820 |
| Company Name | CUSTOM HEALTHCARE SYSTEMS, INC. |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811870034121 [Primary] |
| GS1 | 20811870034125 [Package] Contains: 00811870034121 Package: N/A [5 Units] In Commercial Distribution |
| OES | Cardiac Catheterization Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
[20811870034125]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-27 |
| Device Publish Date | 2018-07-26 |