N/A

GUDID 04961333241934

CONNECTOR CLEANING

PENTAX OF AMERICA, INC.

Endoscopic device sterilization/disinfection tubing set

• Primary Device ID: 04961333241934
• NIH Device Record Key: b024e2d2-0ec6-465e-9ba1-4ba0a8de845e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 2-8-536HAN
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333241934 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063876

FDA Product Code

• FEB: Accessories, Cleaning, For Endoscope

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: 2019-11-08
• Device Publish Date: 2018-03-06

On-Brand Devices [N/A]

• 04961333245406: v4.0 CSL WIN10 UPGRADE
• 04961333245314: MS SQL ENT - 8 CORE LIC (RUNTIME)
• 04961333245307: MS SQL ENT - 4 CORE LIC (RUNTIME)
• 04961333245291: STANDALONE IMAGE CAPTURE PC
• 04961333245284: KEYBOARD FOR EPK-3000
• 04961333245277: CBL,DVID-DVID,6
• 04961333245260: CBL,3.5ST-3.5ST,5,EPK-3000
• 04961333245253: CBL,RGB,9DM-4BNC,5,EPK-3000
• 04961333245246: CBL,BNC-BNC,6, EPK-3000
• 04961333245239: FOOTSWITCH, EPK-3000
• 04961333245222: LAMP FOR EPK-3000
• 04961333245215: FORCEPS TOOTHEDCUP,1.8DIA 60L
• 04961333245192: MIC PRE-AMP KIT (ROLLS MP-13)
• 04961333245185: DEMO CASE FOR POLE STAND
• 04961333245178: DEMO CASE FOR SCOPE, PROCESSOR & MONITOR
• 04961333244706: MS SQL STD SINGLE USER LICENSE
• 04961333244447: SCOPE PROCESSOR/MONITOR INTEGRATION PKG
• 04961333244430: CABLE MANAGEMENT CLIP (5 PACK)
• 04961333244423: UP-X898MD B&W VIDEO PRINTER
• 04961333244416: FILM PACK B&W 240 PRINTS 897MD 10PC
• 04961333244409: FILM PACK 100 PRINTS RIBBON 55MD 2PC
• 04961333244393: FILM PACK 200 PRINTS RIBBON 51MDU/D50
• 04961333244386: FILM PACK 50 PRINTS RIBBON 21/20MD 4PC
• 04961333244348: POWER STRIP/CABLE CLEAT
• 04961333244324: POWER SUPPLY HOLDER/CABLE CLEAT
• 04961333244317: TRAY 30.4 CM X 40.6 CM FOR 2"/5 CM POST
• 04961333244300: HANDLE FOR 2"/5 CM POST
• 04961333244294: UTILITY BASKET
• 04961333244287: ADAPTER FOR 70K WITH FWJ
• 04961333244270: ADAPTER FOR 70K W/O FWJ
• 04961333244263: ADAPTER FOR EB-70K
• 04961333244256: CABLE, RGB W/SYNC 6FT. FOR EPK
• 04961333244249: CBL,4BNC-4BNC,25 VIDEO
• 04961333244232: CBL,4BNC-4BNC,15 VIDEO
• 04961333244225: CBL,BNC-BNC,6 VIDEO
• 04961333244218: CBL,BNC-BNC,25 VIDEO
• 04961333244201: CBL,BNC-BNC,12 VIDEO
• 04961333244195: HEAVY DUTY MONITOR POLE STAND
• 04961333244188: WATER BOTTLE, REUSABLE
• 04961333244171: STANDARD BITE BLOCKS, 3 PIECES
• 04961333244164: RUBBER SUCT VALVE 10 PCS DISPO
• 04961333243990: MS SQL STD SINGLE SVR & USER LICENSE
• 04961333243983: MS SQL STD - 8 CORE LICENSE
• 04961333243976: MS SQL STD - 4 CORE LICENSE
• 04961333243969: 24" STANDARD MONITOR
• 04961333243952: DUAL SCOPE HOLDER TYPE II FOR PREC. CART
• 04961333243945: DRAWER, DEEP FOR PREC. CART
• 04961333243426: BITE BLOCK 3PCS ST
• 04961333243419: SUCTION VALVE, 2 PCS
• 04961333243402: VALVE, SUCTION 10 PCS