Primary Device ID | 10843356100300 |
NIH Device Record Key | 40027295-0196-45fd-bd72-921052629706 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | First Step Bedside Add Water Kit - Resealable Stand-Up Pouch, Endoscopic Cleanin |
Version Model Number | EP-6W |
Company DUNS | 103169095 |
Company Name | CYGNUS MEDICAL L.L.C. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00843356100303 [Primary] |
GS1 | 10843356100300 [Package] Contains: 00843356100303 Package: [120 Units] In Commercial Distribution |
MNL | Accessories, Cleaning Brushes, For Endoscope |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-10-02 |
Device Publish Date | 2020-09-24 |
30843356102674 - CYGNUS | 2024-03-04 12"x23" Tray Liner 50 parts per bag. |
10843356102687 - CYGNUS | 2024-03-04 23"x23" Tray Liner 50 parts per bag |
10843356102717 - CYGNUS | 2024-03-04 12"x12" Tray Liner 50 parts per bag |
10843356102724 - CYGNUS | 2024-03-04 12"x16" Tray Liner 50 parts per bag |
10843356102731 - CYGNUS | 2024-03-04 12"x18" Tray Liner 50 parts per bag |
10843356102700 - Air Time | 2024-02-09 AIRTIME™ HORIZONTAL DRYING, DIRECTIONAL FLOW TUBING SET. USED FOR DRYING COILED SCOPES. 4 TUBING PORTS |
30843356100649 - SingleCycle Biohazard Self-Sealing label 20" | 2023-12-08 SingleCycle Biohazard Self-Sealing label 20" 500 per case |
30843356102391 - SingleCycle Biohazard Self-Sealing label 15" | 2023-12-08 SingleCycle Biohazard Self-Sealing label 15" 500 per case |