HIgH-Flo™ LRVY
GUDID 10659443000688
Low Residual Volume Y-Connector
REPRO MED SYSTEMS, INC.
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 | 10659443000688 |
| NIH Device Record Key | 0059bda9-c513-4933-b8ec-1f790d9bd899 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HIgH-Flo™ |
| Version Model Number | LRVY |
| Catalog Number | LRVY |
| Company DUNS | 048403299 |
| Company Name | REPRO MED SYSTEMS, INC. |
| Device Count | 1 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com | |
| Phone | +1(845)610-5587 |
| fma@rmsmedpro.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00659443000681 [Primary] |
| GS1 | 10659443000688 [Package] Contains: 00659443000681 Package: Carton [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K933652
FDA Product Code
| FRN | Pump, infusion |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
[10659443000688]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-19 |
Devices Manufactured by REPRO MED SYSTEMS, INC.
| 00659443004450 - KORU | 2024-01-24 Freedom60 Infusion Pump with Prefilled Syringe Adapter |
| 00659443003132 - KORU | 2023-12-26 Freedom60 Prefilled Syringe Adapter |
| 10659443002859 - HIgH-Flo™ Needle Set | 2019-06-05 26 Gauge Needle Sets 2 leg 9mm |
| 10659443002835 - HIgH-Flo™ Needle Set | 2019-05-30 26 Gauge Needle Sets 2 leg 4mm |
| 10659443002866 - HIgH-Flo™ Needle Set | 2019-05-30 26 Gauge Needle Sets 2 leg 12mm |
| 10659443002781 - HIgH-Flo™ Needle Set | 2019-05-24 26 Gauge Needle Sets 1 leg 4mm |
| 10659443002798 - HIgH-Flo™ Needle Set | 2019-05-24 26 Gauge Needle Sets 1 leg 6mm |
| 10659443002804 - HIgH-Flo™ Needle Set | 2019-05-24 26 Gauge Needle Sets 1 leg 9mm |
Trademark Results [HIgH-Flo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HIGH-FLO 97372038 not registered Live/Pending |
Repro Med Systems, Inc. 2022-04-20 |
 HIGH-FLO 73623470 1453933 Live/Registered |
GRACO INC. 1986-10-01 |
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