VersaRate FP-0010003
GUDID 00817708020304
Variable Infusion Flow Rate Controller set
EMED TECHNOLOGIES CORPORATION
Mechanical infusion pump administration set| Primary Device ID | 00817708020304 |
| NIH Device Record Key | e690569f-fb57-4937-9e3b-61dd5f4063e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VersaRate |
| Version Model Number | VersaRate |
| Catalog Number | FP-0010003 |
| 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
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817708020298 [Unit of Use] |
| GS1 | 00817708020304 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123729
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 [VersaRate]
| 00817708020540 | Variable Infusion Flow Rate Controller set |
| 00817708020304 | Variable Infusion Flow Rate Controller set |
Trademark Results [VersaRate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSARATE 85435276 4369245 Live/Registered |
EMED Technologies Corporation 2011-09-29 |
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