| Primary Device ID | 20811870030899 |
| NIH Device Record Key | f76ca6ed-ae9e-481f-bbdc-83634a982111 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Custom Healthcare Systems Inc. |
| Version Model Number | R1635 |
| 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 | 00811870030895 [Primary] |
| GS1 | 20811870030899 [Package] Contains: 00811870030895 Package: N/A [50 Units] In Commercial Distribution |
| OKV | Obstetrical Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
[20811870030899]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-27 |
| Device Publish Date | 2018-07-27 |