Toothette Oral Care 6592
GUDID 50618029821336
Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
Oral care kit, single-use| Primary Device ID | 50618029821336 |
| NIH Device Record Key | 2ef7c90f-4253-440c-86ef-f58ed6030145 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Toothette Oral Care |
| Version Model Number | 6592 |
| Catalog Number | 6592 |
| 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
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00618029821331 [Primary] |
| GS1 | 50618029821336 [Package] Contains: 00618029821331 Package: case [10 Units] In Commercial Distribution |
FDA Product Code
| KXF | APPLICATOR, ABSORBENT TIPPED, NON-STERILE |
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 [Toothette Oral Care]
| 50618029830451 | Q4 Oral Cleansing & Suctioning System |
| 50618029821343 | Q4 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse |
| 50618029821336 | Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse |
| 50618029821176 | Untreated Suction Toothbrush, Suction Swab, and Applicator Swab |
| 50618029821169 | Suction Toothbrush with Perox-A-Mint Solution and Mouth Moisturizer |
| 50618029821152 | Suction Swab System with Perox-A-Mint Solution |
| 50618029821107 | Oral Hygiene Kit, Suction Brush with Antiseptic Oral Rinse and Mouth Moisturizer |
| 50618029821053 | Suction Toothbrush with Perox-A-Mint Solution |
| 50618029821008 | Oral Hygiene Kit, Suction Swabs with Antiseptic Oral Rinse and Mouth Moisturizer |
| 50618029820971 | Suction Toothbrushes with Perox-A-Mint Solution |
| 50618029810323 | Disposable Bite Block for Oral Control |
| 50618029800652 | Suction Swab System with Perox-A-Mint Solution |
| 50618029800645 | Suction Swabs with Perox-A-Mint Solution and Mouth Moisturizer |
| 50618029800638 | Suction Swabs with Perox-A-Mint Solution |
| 50618029800607 | Q2 Oral Cleansing & Suctioning System |
| 50618029830512 | Sales Demonstration Sample- Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluco |
Trademark Results [Toothette Oral Care]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TOOTHETTE ORAL CARE 76144475 2614211 Live/Registered |
SAGE PRODUCTS, INC. 2000-10-10 |
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