Res-Q-Vac R1F1S1C1S
GUDID 00659443002616
REPL FSP SFT 10F 35/14 14FR 14 ST
REPRO MED SYSTEMS, INC.
Emergency airway clearance suction system, manual| Primary Device ID | 00659443002616 |
| NIH Device Record Key | 180ca3ce-e86b-44e7-a3d1-c50d74b4993a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Res-Q-Vac |
| Version Model Number | R1F1S1C1S |
| Catalog Number | R1F1S1C1S |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| 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 | |
| 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 | 00659443002616 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K894299
FDA Product Code
| BSY | CATHETERS, SUCTION, TRACHEOBRONCHIAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
[00659443002616]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-08-23 |
| Device Publish Date | 2016-08-19 |
On-Brand Devices [Res-Q-Vac]
| 00659443002777 | Pump NSC Soft 8FR 35/14 NS |
| 00659443002760 | RES-Q-VAC BULK PACK MILITARY |
| 00659443002753 | REPL NSC RGD/SFT 10FR 35/14 14FR 14 |
| 00659443002746 | REPL FSP RIGID ET 8FR 3.5/14 NS |
| 00659443002739 | Ped Non-Sterile Canister Assembly |
| 00659443002708 | RES-Q-VAC®Pump - Bulk |
| 00659443002692 | DENTAL-E-VAC KIT W/PED NS |
| 00659443002685 | DENTAL SOFT FSP REPL NS |
| 00659443002678 | DENTAL-E-VAC REPL FSP NS |
| 00659443002661 | DENTAL-E-VAC KIT W/FSP NS |
| 00659443002654 | PLACKVAC ASSEMBLY |
| 00659443002647 | PLACKVAC1 REPLACEMENT KIT NS |
| 00659443002630 | REPL FSP SOFT 8FR 3.5 NS |
| 00659443002623 | REPL FSP SFT 14FR 14 ST |
| 00659443002616 | REPL FSP SFT 10F 35/14 14FR 14 ST |
| 00659443002609 | REPL FSP S0FT 8FR 10FR 35/14 ST |
| 00659443002593 | REPL FSP S0FT 14FR 35/14 ST |
| 00659443002586 | REPL FSP SOFT 10FR 35/14 NS |
| 00659443002579 | REPL FSP SFT 10F 35/14 14F 14 NS V |
| 00659443002562 | REPL FSP SOFT ST |
| 00659443002555 | REPL FSP SOFT NS |
| 00659443002548 | REPL FSP RGD 14FR 14 ST |
| 00659443002531 | REPL FSP RGD 8/10FR 35/14 ST |
| 00659443002524 | REPL FSP RIGID 10FR 35/14 CATH NS |
| 00659443002517 | REPL FSP RIGID 10/14FR 14 CATH ST |
| 00659443002500 | REPL FSP RIGID ST |
| 00659443002494 | REPL FSP RIGID NS |
| 00659443002487 | REPL FSP RIGID ET 10FR 35/14 NS |
| 00659443002470 | REPL FSP R/S ALL Catheter ST |
| 00659443002463 | REPL 1 FSP RG/SF ALL 14 CAT ST |
| 00659443002456 | REPL FSP RGD/SFT 14FR 35/14 ST |
| 00659443002449 | REPL FSP R/S 10FR 35/14 ST |
| 00659443002432 | REPL FSP R/S 10FR 35/14 NS LED |
| 00659443002425 | REPL FSP R/S 10FR 35/14 NS |
| 00659443002418 | DENTAL FSP SALIVA EJECT REPL |
| 00659443002401 | REPL FSP RGD/SFT 10/14FR 14 ST |
| 00659443002395 | REPL FSP Rigid/ Soft ST |
| 00659443002388 | REPL FSP 2-14FR 14 Cath ST |
| 00659443002371 | REPL FSP 8FR 14 Catheter NS |
| 00659443002364 | REPL FSP All Catheters ST |
| 00659443002357 | REPL FSP All Catheters NS |
| 00659443002340 | REPL FSP 8/10FR 35/14 ST |
| 00659443002333 | REPL FSP 14FR 35/14 ST |
| 00659443002326 | REPL FSP 10FR 35/14 ST |
| 00659443002319 | REPL FSP 8FR 3.5/14 Cath Sterile |
| 00659443002289 | PUMP 2NSC RGD/SFT ALL CATH ST |
| 00659443002272 | PUMP 2FSP 2SOFT ALL CATH ST |
| 00659443002265 | PUMP 2FSP 2SOFT ST |
| 00659443002258 | PUMP 2FSP 2RGID ST |
| 00659443002241 | PUMP 2FSP 2RGD/SFT ALL CATH ST |
Trademark Results [Res-Q-Vac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RES-Q-VAC 74057230 1762635 Live/Registered |
REPRO-MED SYSTEMS, INC. 1990-05-09 |
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