Res-Q-Vac P1F1B1AFNLED

GUDID 00659443001541

PUMP FSP R/S ALL CATHETER NS LED

REPRO MED SYSTEMS, INC.

Emergency airway clearance suction system, manual

• Primary Device ID: 00659443001541
• NIH Device Record Key: b7de8f46-decf-40a4-8520-00cffb593e15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Res-Q-Vac
• Version Model Number: P1F1B1AFNLED
• Catalog Number: P1F1B1AFNLED
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00659443001541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894299

FDA Product Code

• BSY: CATHETERS, SUCTION, TRACHEOBRONCHIAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

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