Blu-Mousse® S438
GUDID 10810000524164
Classic Blu-Mousse® Cartridges
PARKELL, INC.
Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material| Primary Device ID | 10810000524164 |
| NIH Device Record Key | 5baa0dc2-2ea3-4e68-b0bf-df6ca0809462 |
| Commercial Distribution Discontinuation | 2022-12-02 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Blu-Mousse® |
| Version Model Number | S438 |
| Catalog Number | S438 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 2 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000524167 [Unit of Use] |
| GS1 | 10810000524164 [Primary] |
FDA Product Code
| ELW | Material, Impression |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-04-13 |
| Device Publish Date | 2018-10-19 |
On-Brand Devices [Blu-Mousse®]
| M595S4360 | Tubes of Classic Blu-Mousse® |
| M595S4571 | Super-Fast Blu-Mousse® Standard-Cartridge System |
| M595S448S1 | Peppermint Super-Fast Blu-Mousse® In Split-Cartridge System |
| M595S440S1 | Blu-Mousse® 60 In Split-Cartridge |
| M595S4381 | Classic Blu-Mousse® Standard-Cartridge System |
| M595S437S1 | Peppermint Classic Blu-Mousse® In Split-Cartridge System |
| M595S457S0 | Super-Fast Blu-Mousse® Split-Cartridge System |
| M595S438S0 | Classic Blu-Mousse® In Split-Cartridge System |
| 00810000524211 | Super-Fast Blu-Mousse® Standard-Cartridge System (Korea) |
| 00810000524167 | Classic Blu-Mousse® in Standard Cartridges (Korea) |
| 00810000524228 | Super-Fast Blu-Mousse® Split-Cartridge System (Korea) |
| 00810000524181 | Blu-Mousse® 60 In Split-Cartridge (Korea) |
| 00810000524174 | Classic Blu-Mousse® In Split-Cartridge System (Korea) |
| 00810000524501 | Tubes of Classic Blu-Mousse® (Korea) |
| 10810000526984 | Mixing Tip for Standard Cartridge for use with Blu-Mousse® (Pkg. of 30 pcs.) |
| 10810000526977 | Snap-In Intraoral Tip for Use in S439K, S445 & S496 Mixing Tips (Pkg. of 50 pcs.) |
| 10810000524218 | Super-Fast Blu-Mousse® Standard-Cartridge System |
| 10810000524164 | Classic Blu-Mousse® Cartridges |
| 10810000524195 | Peppermint Super-Fast Blu-Mousse® In Split-Cartridge System |
| 10810000524188 | Blu-Mousse® 60 In Split-Cartridge |
| 10810000524157 | Peppermint Classic Blu-Mousse® In Split-Cartridge System |
Trademark Results [Blu-Mousse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BLU-MOUSSE 73685563 1486672 Live/Registered |
PARKELL PRODUCTS INC. 1987-09-21 |
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