AccuFlo FLO-100
GUDID 00817708020229
Fluid Delivery Set
EMED TECHNOLOGIES CORPORATION
Intravenous administration set| 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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