EnsoETM
GUDID 20857915006122
The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient’s temperature, allow enteral administration of fluid, and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block, an ENFit transition adaptor, and lubrication jelly.
Attune Medical
Thermal-regulation orogastric tube| Primary Device ID | 20857915006122 |
| NIH Device Record Key | 90a3e67a-6a27-4607-b3f3-b0b7ae240010 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EnsoETM |
| Version Model Number | ECD05-A |
| Company DUNS | 961627382 |
| Company Name | Attune Medical |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857915006128 [Primary] |
| GS1 | 10857915006125 [Package] Contains: 00857915006128 Package: Shelf Box [4 Units] In Commercial Distribution |
| GS1 | 20857915006122 [Package] Contains: 10857915006125 Package: Shipping Box [1 Units] In Commercial Distribution |
FDA Product Code
| PIO | Enteral Specific Transition Connectors |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-09 |
| Device Publish Date | 2018-09-08 |
On-Brand Devices [EnsoETM]
| 20857915006221 | The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Blanket |
| 20857915006207 | The EnsoETM is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III Condu |
| 20857915006184 | The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Blanket |
| 20857915006160 | The EnsoETM is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III Condu |
| 20857915006146 | The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Norm-O- |
| 20857915006122 | The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Norm-O- |
| 20857915006054 | The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Blanket |
| 20857915006047 | The EnsoETM is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III Condu |
Trademark Results [EnsoETM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENSOETM 87382831 5429773 Live/Registered |
ADVANCED COOLING THERAPY, INC. 2017-03-23 |
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