LEADER 5238506

GUDID 50096295128784

LDR Pediatric Nebulizer System Betty the Pig

CARDINAL HEALTH, INC.

Nebulizing system, non-heated

• Primary Device ID: 50096295128784
• NIH Device Record Key: 627dacb3-92aa-430b-9fc2-12a43783e90d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEADER
• Version Model Number: 5238506
• Catalog Number: 5238506
• Company DUNS: 097537435
• Company Name: CARDINAL HEALTH, 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: false
• 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: true

Customer Support Contacts

• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 13 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00096295128789 [Primary]
GS1	50096295128784 [Package]; Contains: 00096295128789; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043238

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-23

On-Brand Devices [LEADER]

• 00096295129229: LDR Blood Glucose Monitoring System
• 50096295133443: LDR GLOVE NITRILE EXAM 100 XL PWF
• 50096295133436: LDR GLOVE NITRILE EXAM 100 LG PWF
• 50096295133429: LDR GLOVE NITRILE EXAM 100 MD PWF
• 50096295133412: LDR GLOVE NITRILE EXAM 100 SM PWF
• 50096295133405: LDR GLOVE VINYL EXAM 100 SM PWF
• 50096295133399: LDR GLOVE VINYL EXAM 100 XL PWF
• 50096295133382: LDR GLOVE VINYL EXAM 100 LRG PWF
• 50096295133375: LDR GLOVE VINYL EXAM 100 MD PWF
• 50096295133368: LDR GLOVE LATEX EXAM 100 XL PWF
• 50096295133351: LDR GLOVE LATEX EXAM 100 LRG PWF
• 50096295133344: LDR GLOVE LATEX EXAM 100 MD PWF
• 50096295133337: LDR GLOVE LATEX EXAM 100 SM PWF
• 50096295131388: LDR Pulse Oximeter Portable 1 ea
• 30096295131377: LDR Deluxe Pulse Oximeter Portable 1 ea
• 00096295130799: LDR Digital Thermometer 60 seconds
• 50096295130787: LDR Digital Thermometers 9 sec Display box of 9 ea
• 30096295130370: LDR TENS Electro-Therapy Kit 1 ea
• 30096295130363: LDR Electro TENS replacement gel pads 3 ea
• 30096295130110: LDR Thermometer Instant Read Digital Temple non-invasive
• 30096295130103: LDR Instant Digital Ear Thermometer
• 50096295130091: LDR Fever-glow Instant Ear Thermometer
• 50096295130084: LDR Temple Touch Temple Thermometer
• 50096295130077: LDR Thermometer 20 second flex tip
• 30096295130066: LDR Digital Thermometer Probe covers
• 50096295130053: LDR Thermometer 10 second (dishwasher safe)
• 50096295129323: LDR Blood Pressure Home Kit with manual Stethoscope
• 50096295129316: LDR Blood Pressure Monitor, automatic
• 50096295129309: LDR Blood Pressure Monitor, Automatic Wrist
• 50096295129293: LDR Blood Pressure Monitor, Deluxe Automatic Wrist
• 50096295129286: LDR Blood Pressure Monitor, Deluxe automatic
• 50096295129279: LDR Blood Pressure Monitor, Premium Automatic
• 50096295129217: LDR All-in-One Nebulizer System
• 30096295129183: LDR Glucose Control Solution 3x2mL solutions
• 50096295129170: LDR Blood Glucose Test Strips 100 ct
• 50096295129163: LDR Blood Glucose Test Strips 50 ct
• 30096295129152: LDR Blood Glucose Test Strips 25 ct
• 50096295128791: LDR Pediatric Nebulizer System Pete the Dog
• 50096295128784: LDR Pediatric Nebulizer System Betty the Pig
• 50096295125592: LDR Unifine Pentips Plus Micro 32G x 4mm 100 pen needles
• 50096295122201: LDR Heating Pad Moist / Dry King Size Electric 60-minute auto-off
• 50096295120900: LDR Unifine Pentips Plus Short 31G x 8mm 100 pen needles
• 30096295120890: LDR Unifine Pentips Plus Mini 31G x 5mm 100 pen needles
• 50096295116736: LDR Heating Pad Moist / Dry Electric 60-minute auto-off
• 50096295102807: Leader Waterproof Adhesive Tape; 1/2 in. x 10 yd.
• 20096295129247: Interior package vial label for 10 ct test strips
• 20096295129162: Interior package vial label for 50 ct test strips
• 20096295129155: Interior package vial label for 25 ct test strips
• 50096295135850: Leader Urinary Tract Infection Home Test, 3 COUNT
• 50096295131555: Drug Free Nasal Strips; Opens Nasal Passages for Easier Breathing; Relieves Nasal Congestion Due