AccuFlo FLO-100
GUDID 00817708020229
Fluid Delivery Set
EMED TECHNOLOGIES CORPORATION
Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Intravenous administration set Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive| Primary Device ID | 00817708020229 |
| NIH Device Record Key | 7e5ba38b-8cf1-4c4e-8228-c72e4594b807 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccuFlo |
| Version Model Number | FLO-100 |
| Catalog Number | FLO-100 |
| Company DUNS | 622637544 |
| Company Name | EMED TECHNOLOGIES CORPORATION |
| Device Count | 50 |
| 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 Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
| Storage Environment Temperature | Between -5 Degrees Fahrenheit and 40 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817708020212 [Unit of Use] |
| GS1 | 00817708020229 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K935642
FDA Product Code
| FPK | Tubing, Fluid Delivery |
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 | 2019-12-11 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [AccuFlo]
| 00817708020267 | Fluid Delivery Set |
| 00817708020243 | Fluid Delivery Set |
| 00817708020229 | Fluid Delivery Set |
Trademark Results [AccuFlo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUFLO 90474495 not registered Live/Pending |
EMED Technologies Corporation 2021-01-19 |
 ACCUFLO 88736189 not registered Live/Pending |
Lacrimedics, Inc. 2019-12-20 |
 ACCUFLO 87702629 not registered Live/Pending |
Arborjet, Inc. 2017-11-30 |
 ACCUFLO 87577417 5559013 Live/Registered |
Van Daalwyk, Dennis 2017-08-21 |
 ACCUFLO 87531305 not registered Dead/Abandoned |
Pantex Ennerflo Systems Inc. 2017-07-17 |
 ACCUFLO 85744606 not registered Dead/Abandoned |
Resolve Specialty Products 2012-10-03 |
 ACCUFLO 78255716 2853755 Dead/Cancelled |
TRUE VALUE COMPANY 2003-05-29 |
 ACCUFLO 77740339 3823768 Dead/Cancelled |
OPW FUELING COMPONENTS INC. 2009-05-19 |
 ACCUFLO 77103666 3513221 Live/Registered |
Comco, Inc. 2007-02-09 |
 ACCUFLO 76602341 2993988 Live/Registered |
PETRO-CANADA LUBRICANTS INC. 2004-07-14 |
 ACCUFLO 75299181 2257744 Dead/Cancelled |
Cargill, Incorporated 1997-05-28 |
 ACCUFLO 75215491 not registered Dead/Abandoned |
Fluoroware, Inc. 1996-12-19 |
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