Infuset FP-0010007
GUDID 00817708020380
Infusion Flow Rate Controller set
EMED TECHNOLOGIES CORPORATION
Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set| Primary Device ID | 00817708020380 |
| NIH Device Record Key | 8c592184-cb99-4c35-a660-b1076c1e7e70 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Infuset |
| Version Model Number | Infuset-290 |
| Catalog Number | FP-0010007 |
| 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 | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 Milliliter |
| Length | 57.16 Centimeter |
| Total Volume | 0.16 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 | 00817708020373 [Unit of Use] |
| GS1 | 00817708020380 [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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.