HIgH-Flo™ Needle Set RMS62612
GUDID 10659443000510
26 Gauge Needle Sets - 6 needles - 12 mm
REPRO MED SYSTEMS, INC.
Subcutaneous injection/infusion port needle| Primary Device ID | 10659443000510 |
| NIH Device Record Key | 2fe889a2-8a5a-49fe-9839-feccb0a19aa6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HIgH-Flo™ Needle Set |
| Version Model Number | RMS62612 |
| Catalog Number | RMS62612 |
| 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 Dimensions
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
| Needle Gauge | 26 Gauge |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00659443000513 [Primary] |
| GS1 | 10659443000510 [Package] Contains: 00659443000513 Package: Carton [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122404
FDA Product Code
| FPA | Set, administration, intravascular |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
Radiation Sterilization
[10659443000510]
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 |
On-Brand Devices [HIgH-Flo™ Needle Set]
| 10659443000671 | 24 Gauge Needle Sets - 4 needles - 12 mm |
| 10659443000664 | 24 Gauge Needle Sets - 4 needles - 9 mm |
| 10659443000657 | 24 Gauge Needle Sets - 4 needles - 6 mm |
| 10659443000640 | 24 Gauge Needle Sets - 3 needles - 14 mm |
| 10659443000633 | 24 Gauge Needle Sets - 3 needles - 12 mm |
| 10659443000626 | 24 Gauge Needle Sets - 3 needles - 9 mm |
| 10659443000619 | 24 Gauge Needle Sets - 3 needles - 6 mm |
| 10659443000602 | 24 Gauge Needle Sets - 2 needles - 14 mm |
| 10659443000596 | 24 Gauge Needle Sets - 2 needles - 12 mm |
| 10659443000589 | 24 Gauge Needle Sets - 2 needles - 9 mm |
| 10659443000572 | 24 Gauge Needle Sets - 2 needles - 6 mm |
| 10659443000565 | 24 Gauge Needle Sets - 1 needle - 14 mm |
| 10659443000558 | 24 Gauge Needle Sets - 1 needle - 12 mm |
| 10659443000541 | 24 Gauge Needle Sets - 1 needle - 9 mm |
| 10659443000534 | 24 Gauge Needle Sets - 1 needle - 6 mm |
| 10659443000527 | 26 Gauge Needle Sets - 6 needles - 14 mm |
| 10659443000510 | 26 Gauge Needle Sets - 6 needles - 12 mm |
| 10659443000503 | 26 Gauge Needle Sets - 6 needles - 9 mm |
| 10659443000497 | 26 Gauge Needle Sets - 6 needles - 6 mm |
| 10659443000480 | 26 Gauge Needle Sets - 6 needles - 4 mm |
| 10659443000473 | 26 Gauge Needle Sets - 5 needles - 14 mm |
| 10659443000466 | 26 Gauge Needle Sets - 5 needles - 12 mm |
| 10659443000459 | 26 Gauge Needle Sets - 5 needles - 9 mm |
| 10659443000442 | 26 Gauge Needle Sets - 5 needles - 6 mm |
| 10659443000435 | 26 Gauge Needle Sets - 5 needles - 4 mm |
| 10659443000428 | 26 Gauge Needle Sets - 4 needles - 14 mm |
| 10659443000411 | 26 Gauge Needle Sets - 4 needles - 12 mm |
| 10659443000404 | 26 Gauge Needle Sets - 4 needles - 9 mm |
| 10659443000398 | 26 Gauge Needle Sets - 4 needles - 6 mm |
| 10659443000381 | 26 Gauge Needle Sets - 4 needles - 4 mm |
| 10659443000374 | 26 Gauge Needle Sets - 3 needles - 14 mm |
| 10659443000367 | 26 Gauge Needle Sets - 3 needles - 12 mm |
| 10659443000350 | 26 Gauge Needle Sets - 3 needles - 9 mm |
| 10659443000343 | 26 Gauge Needle Sets - 3 needles - 6 mm |
| 10659443000336 | 26 Gauge Needle Sets - 3 needles - 4 mm |
| 10659443000329 | 26 Gauge Needle Sets - 2 needles - 14 mm |
| 10659443000312 | 26 Gauge Needle Sets - 2 needles - 12 mm |
| 10659443000305 | 26 Gauge Needle Sets - 2 needles - 9 mm |
| 10659443000299 | 26 Gauge Needle Sets - 2 needles - 6 mm |
| 10659443000282 | 26 Gauge Needle Sets - 2 needles - 4 mm |
| 10659443000275 | 26 Gauge Needle Sets - 1 needle - 14 mm |
| 10659443000268 | 26 Gauge Needle Sets - 1 needle - 12 mm |
| 10659443000251 | 26 Gauge Needle Sets - 1 needle - 6 mm |
| 10659443000244 | 26 Gauge Needle Sets - 1 needle - 9 mm |
| 10659443000237 | 26 Gauge Needle Sets - 1 needle - 4 mm |
| 10659443003078 | 26 Gauge Needle Sets 6 leg 14mm |
| 10659443003061 | 26 Gauge Needle Sets 6 leg 12mm |
| 10659443003054 | 26 Gauge Needle Sets 6 leg 9mm |
| 10659443003047 | 26 Gauge Needle Sets 6 leg 6mm |
| 10659443003030 | 26 Gauge Needle Sets 6 leg 4mm |
Trademark Results [HIgH-Flo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HIGH-FLO 98679297 not registered Live/Pending |
KORU Medical Systems, Inc. 2024-08-02 |
 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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