DOSI-FUSER
GUDID 18436020762175
Elastomeric Infusion Pump
LEVENTON SAU
Elastomeric infusion pump system| Primary Device ID | 18436020762175 |
| NIH Device Record Key | b63060ba-d1b1-4e45-b29c-8e0912f8ffe1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DOSI-FUSER |
| Version Model Number | L25915-250D1-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 | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 Milliliter |
| Total Volume | 250 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 |
| 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 | 08436020762178 [Primary] |
| GS1 | 18436020762175 [Package] Contains: 08436020762178 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 | 2016-08-24 |
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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