Q-Care Rx 9002
GUDID 50618029830253
Q-Care Rx Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
Dental tooth-cleaning solution| Primary Device ID | 50618029830253 |
| NIH Device Record Key | 13e7ebdb-2433-4d10-8d45-0bf803768cd5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Q-Care Rx |
| Version Model Number | 9002 |
| Catalog Number | 9002 |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00618029830258 [Primary] |
| GS1 | 50618029830253 [Package] Contains: 00618029830258 Package: case [20 Units] In Commercial Distribution |
FDA Product Code
| NSB | Patient personal hygiene kit |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Q-Care Rx]
| 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 |
Trademark Results [Q-Care Rx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 Q-CARE RX 77188773 3535957 Live/Registered |
Sage Products, Inc. 2007-05-23 |
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