Infuset FP-0010013
GUDID 00817708020489
Infusion Flow Rate Controller set
EMED TECHNOLOGIES CORPORATION
Mechanical infusion pump administration set| Primary Device ID | 00817708020489 |
| NIH Device Record Key | 387de0ca-b1f7-4f0a-b776-9160e325ad8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Infuset |
| Version Model Number | Infuset-45 |
| Catalog Number | FP-0010013 |
| Company DUNS | 622637544 |
| Company Name | EMED TECHNOLOGIES CORPORATION |
| Device Count | 25 |
| 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 |
Customer Support Contacts
Device Dimensions
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
| Length | 96.21 Centimeter |
| Total Volume | 0.15 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817708020472 [Unit of Use] |
| GS1 | 00817708020489 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140133
FDA Product Code
| FPA | Set, Administration, Intravascular |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [Infuset]
| 00817708021943 | Infusion Flow Rate Controller set |
| 00817708021929 | Infusion Flow Rate Controller set |
| 00817708021905 | Infusion Flow Rate Controller set |
| 00817708020502 | Infusion Flow Rate Controller set |
| 00817708020489 | Infusion Flow Rate Controller set |
| 00817708020465 | Infusion Flow Rate Controller set |
| 00817708020441 | Infusion Flow Rate Controller set |
| 00817708020427 | Infusion Flow Rate Controller set |
| 00817708020403 | Infusion Flow Rate Controller set |
| 00817708020380 | Infusion Flow Rate Controller set |
| 00817708020366 | Infusion Flow Rate Controller set |
| 00817708020342 | Infusion Flow Rate Controller set |
| 00817708020328 | Infusion Flow Rate Controller set |
Trademark Results [Infuset]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INFUSET 90474489 not registered Live/Pending |
EMED Technologies Corporation 2021-01-19 |
 INFUSET 72177380 0769232 Dead/Cancelled |
Sorenson Research Corp. 1963-09-19 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.