| Primary Device ID | 20634624431052 |
| NIH Device Record Key | 5aaa84db-cfb2-45d0-9a0f-c7ac90bfec91 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RLV-T Suction Control Device |
| Version Model Number | 4103105 |
| Company DUNS | 041810693 |
| Company Name | QUEST MEDICAL 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | 1-800-627-0226 |
| Custserv@questmedical.com | |
| Phone | 1-800-627-0226 |
| Custserv@questmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00634624431058 [Primary] |
| GS1 | 20634624431052 [Package] Contains: 00634624431058 Package: Shipper [50 Units] In Commercial Distribution |
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-09-29 |
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