| Primary Device ID | 20811870030134 |
| NIH Device Record Key | 80270a27-c022-4060-9954-b7881fba81de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Custom Healthcare Systems Inc. |
| Version Model Number | C10-8569 |
| 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 | 00811870030130 [Primary] |
| GS1 | 20811870030134 [Package] Contains: 00811870030130 Package: N/A [50 Units] In Commercial Distribution |
| OKV | Obstetrical Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
[20811870030134]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-30 |
| Device Publish Date | 2018-07-30 |