Mul-T-Blanket 8001-061-812
GUDID 57613327175054
STRYKER CORPORATION
Circulating-fluid whole-body heating/cooling system pad, reusable| Primary Device ID | 57613327175054 |
| NIH Device Record Key | 61fd06ce-5905-43bd-9ebd-d6de602c8015 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mul-T-Blanket |
| Version Model Number | 8001-061-812 |
| Catalog Number | 8001-061-812 |
| Company DUNS | 078470558 |
| Company Name | STRYKER CORPORATION |
| Device Count | 1 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327175059 [Primary] |
| GS1 | 57613327175054 [Package] Contains: 07613327175059 Package: case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100585
FDA Product Code
| DWJ | System, thermal regulating |
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 | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Mul-T-Blanket]
| 07613327348873 | HP7010 |
| 57613327175351 | 8001-061-612 |
| 57613327175122 | 8001-061-610 |
| 07613327175110 | 8001-061-702 |
| 07613327175097 | 8001-061-701 |
| 57613327175061 | 8001-061-810 |
| 57613327175054 | 8001-061-812 |
Trademark Results [Mul-T-Blanket]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MUL-T-BLANKET 73372510 1279708 Live/Registered |
Medisearch PR, Inc. 1982-07-01 |
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