| Primary Device ID | 20811870033685 |
| NIH Device Record Key | da1cec9a-5331-4293-a227-63df8020fad1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CUSTOM HEALTHCARE SYSTEMS, INC |
| Version Model Number | KM-19370-1 |
| Company DUNS | 175254820 |
| Company Name | CUSTOM HEALTHCARE SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811870033681 [Primary] |
| GS1 | 20811870033685 [Package] Contains: 00811870033681 Package: N/A [20 Units] In Commercial Distribution |
| DWO | Needle, Biopsy, Cardiovascular |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
[20811870033685]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-01 |
| Device Publish Date | 2019-09-23 |