Toothette Oral Care 6594
GUDID 50618029821343
Q4 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab Oral care swab| Primary Device ID | 50618029821343 |
| NIH Device Record Key | 076f9345-2248-4b2e-ab5f-a5062f66e13f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Toothette Oral Care |
| Version Model Number | 6594 |
| Catalog Number | 6594 |
| 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 |
| 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 | 00618029821348 [Primary] |
| GS1 | 50618029821343 [Package] Contains: 00618029821348 Package: case [20 Units] In Commercial Distribution |
FDA Product Code
| JOL | CATHETER AND TIP, SUCTION |
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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