Patient Leadwire

GUDID 90817266020399

Dual Socket Leadwire Socket to Pinch, AAMI Style, 4 Lead Combiner Set, IEC Color Scheme

MERIT CABLES INCORPORATED

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable

• Primary Device ID: 90817266020399
• NIH Device Record Key: 2dc3c0e0-79ab-4126-a9df-d701faf4e085
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Leadwire
• Version Model Number: 80301-X-IEC
• Company DUNS: 180587883
• Company Name: MERIT CABLES INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com
• Phone: 714-918-1935
• Email: rmauricio@meritcables.com

Device Dimensions

• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch
• Length: 120 Inch
• Length: 60 Inch
• Length: 40 Inch
• Length: 24 Inch
• Length: 18 Inch
• Length: 14 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	90817266020399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942321

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [Patient Leadwire]

• 00817266020259: Dual Socket Leadwire Socket to Banana, Marquette Style, Package of 10
• 90817266020863: 3 Lead Wire Assembly: socket connector to snaps
• 90817266020788: 3 Lead Set .080 Socket to Pinch, Various Lengths and Colors
• 90817266020733: 3 Leadwire Set: socket to pinch, (Blk, Wht, Grn), various lengths
• 90817266020719: Leadwire - Socket to Banana Plug, Various Lengths & Colors
• 90817266020429: Dual Socket 5 Leadwire Set, AHA Color Scheme (R, Blk, Brn, Wht, Grn)
• 90817266020412: Dual Socket 3 Lead Set, AHA Color Scheme (R, Blk, Wht)
• 90817266020405: Dual Socket Leadwire Socket to Snap, AAMI Style, Various Lengths & Colors
• 90817266020399: Dual Socket Leadwire Socket to Pinch, AAMI Style, 4 Lead Combiner Set, IEC Color Scheme
• 90817266020382: Dual Socket Leadwire Socket to Pinch, AAMI Style, 4 Lead Combiner Set, AHA Color Scheme
• 90817266020375: Dual Socket 3 Leadwire Set, IEC Color Scheme (R, Grn, Yel).
• 90817266020368: Dual Socket 5 Leadwire Set, AHA Color Scheme (R, Blk, Brn, Wht, Grn)
• 90817266020351: Dual Socket 3 Leadwire Set, AHA Color Scheme (R, Blk, Wht).
• 90817266020344: Dual Socket Leadwire to Pinch, AAMI Style, Various Lengths & Colors
• 90817266020337: Dual Socket Leadwire Socket to Snap, Conmed Style, Various Lengths & Colors.
• 90817266020320: 5 Dual Socket Leadwire Set, AHA Color Scheme (R,Blk, Brn, Wht, Grn)
• 90817266020313: 3 Dual Socket Lead Wire Set, AHA Color Scheme (R, Blk, Wht)
• 90817266020306: Dual Socket Leadwire Socket to Snap, Spacelabs Style, Various Lengths & Colors
• 90817266020290: Dual Socket Leadwire Set VS/VR Style with Combiner
• 90817266020283: Lead Wire Twisted Pair Din Style
• 90817266020276: Lead Wire Set Multilink Style 5 Lead Snap, Various Lengths, AHA Color Scheme
• 90817266020269: Lead Wire Set Multilink Style 3 Lead Snap, Various Lengths, AHA Color Scheme
• 90817266020245: Dual Socket Leadwire Socket to Banana, Marquette Style, Various Lengths & Colors.
• 90817266020238: Dual Socket Leadwire Socket to Pinch Marquette Style, Various Lengths & Colors
• 90817266020221: Din Leadwire Set Bonded, Various Lengths & Colors
• 90817266020214: Leadwire Adapter 125 socket to Termination, Various Lengths & Colors.
• 90817266020207: Din Leadwire Set Bonded, Various Lengths & Colors
• 90817266020191: Leadire Adapter 4mm Socket to Termination, Various Lengths & Colors.
• 90817266020184: Leadwire Adapter 3mm Socket to Termination, Various Lengths & Colors
• 90817266020160: 3 Lead Set AHA Color Scheme (R, Blk, Wht)
• 90817266020153: Din Leadwire Socket to Pinch, Various Lengths & Colors
• 90817266020146: Din Leadwire Socket to Socket, Various Lengths & Colors
• 90817266020139: Din Leadwire .080" Socket to Snap, Various Lengths & Colors
• 90817266020122: 5 Lead Set IEC Color Scheme (R, Grn, Yel, Blk, Wht)
• 90817266020115: 3 Lead Set IEC Color Scheme (Blk, Wht, Grn)
• 90817266020108: 5 Lead Set AHA Color Scheme (R, Blk,Brn, Wht, Grn)
• 90817266020092: 3 Lead Set AHA Color Scheme (R ,Blk, Wht)
• 90817266020085: Din Leadwires Snap to Socket, Various Lengths & Colors