DOSI-FUSER
GUDID 18436020761895
Elastomeric Infusion Pump
LEVENTON SAU
Elastomeric infusion pump system Elastomeric infusion pump system Elastomeric infusion pump system Elastomeric infusion pump system Elastomeric infusion pump system Elastomeric infusion pump system Elastomeric infusion pump system Elastomeric infusion pump system Elastomeric infusion pump system Elastomeric infusion pump system Elastomeric infusion pump system Elastomeric infusion pump system Elastomeric infusion pump system| Primary Device ID | 18436020761895 |
| NIH Device Record Key | 07a43435-193a-4188-99c5-110caeeb7232 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DOSI-FUSER |
| Version Model Number | L25915-065D2-USA |
| Company DUNS | 461437429 |
| Company Name | LEVENTON SAU |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
Device Dimensions
| Total Volume | 65 Milliliter |
| Total Volume | 65 Milliliter |
| Total Volume | 65 Milliliter |
| Total Volume | 65 Milliliter |
| Total Volume | 65 Milliliter |
| Total Volume | 65 Milliliter |
| Total Volume | 65 Milliliter |
| Total Volume | 65 Milliliter |
| Total Volume | 65 Milliliter |
| Total Volume | 65 Milliliter |
| Total Volume | 65 Milliliter |
| Total Volume | 65 Milliliter |
| Total Volume | 65 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08436020761898 [Primary] |
| GS1 | 18436020761895 [Package] Contains: 08436020761898 Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K040752
FDA Product Code
| MEB | Pump, Infusion, Elastomeric |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-11-29 |
| Device Publish Date | 2017-09-12 |
On-Brand Devices [DOSI-FUSER]
| 18436020768276 | Elastomeric Infusion Pump |
| 18436020768269 | Elastomeric Infusion Pump |
| 18436020768252 | Elastomeric Infusion Pump |
| 18436020768023 | Elastomeric Infusion Pump |
| 18436020767729 | Elastomeric Infusion Pump |
| 18436020767477 | Elastomeric Infusion Pump |
| 18436020764858 | Elastomeric Infusion Pump |
| 18436020763882 | Elastomeric Infusion Pump |
| 08436020763878 | Elastomeric Infusion Pump |
| 08436020763861 | Elastomeric Infusion Pump |
| 18436020762175 | Elastomeric Infusion Pump |
| 18436020762106 | Elastomeric Infusion Pump |
| 18436020762038 | Elastomeric Infusion Pump |
| 18436020761895 | Elastomeric Infusion Pump |
| 18436020761864 | Elastomeric Infusion Pump |
| 18436020760089 | Elastomeric Infusion Pump |
| 18436020760065 | Elastomeric Infusion Pump |
| 18436020760058 | Elastomeric Infusion Pump |
| 18436020760027 | Elastomeric Infusion Pump |
| 18436020760010 | Elastomeric Infusion Pump |
Trademark Results [DOSI-FUSER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DOSI-FUSER 79107543 4273860 Live/Registered |
LEVENTON S.A. 2011-12-02 |
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