| Primary Device ID | 50618029830239 |
| NIH Device Record Key | b5947ccc-2ebc-48c4-94d1-464fcadca822 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Q-Care Rx |
| Version Model Number | 6912-PS |
| Catalog Number | 6912-PS |
| Company DUNS | 054326178 |
| Company Name | SAGE PRODUCTS, LLC |
| 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 | true |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00618029830234 [Primary] |
| GS1 | 50618029830239 [Package] Contains: 00618029830234 Package: case [10 Units] In Commercial Distribution |
| JOL | CATHETER AND TIP, SUCTION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-15 |
| Device Publish Date | 2023-09-07 |
| 50618029831144 | Q-Care Rx, Oral cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rins |
| 50618029830468 | Q Care, Q2 Oral Cleansing & Suctioning System, Suction Toothbrush Compatible with Chlorhexidine |
| 50618029830253 | Q-Care Rx Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse |
| 50618029830222 | Sales Demonstration Sample- Q Care Rx, Q2, Oral Cleansing & Suctioning System with 0.12% Chlorhe |
| 50618029830208 | Sales Demonstration Sample- Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhe |
| 50618029830116 | Sales Demonstration Sample, Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhe |
| 50618029830239 | Professional Sales Sample- Q Care Rx, Q2, Oral Cleansing & Suctioning System with 0.12% Chlorhex |
| 50618029830215 | Professional Sales Sample- Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhex |
| 50618029830123 | Professional Sample- Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() Q-CARE RX 77188773 3535957 Live/Registered |
Sage Products, Inc. 2007-05-23 |