CARDINAL HEALTH ESSENTIALS ZRWC16

GUDID 50885380114531

Wound and Skin Cleanser; 16 FL OZ

Cardinal Health 200, LLC

Wound irrigation solution, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute Non-antimicrobial wound irrigation solution, multiple solute

• Primary Device ID: 50885380114531
• NIH Device Record Key: 43719434-05b0-40cf-aa0d-f51f03987164
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARDINAL HEALTH ESSENTIALS
• Version Model Number: ZRWC16
• Catalog Number: ZRWC16
• Company DUNS: 961027315
• Company Name: Cardinal Health 200, LLC
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885380114536 [Primary]
GS1	50885380114531 [Package]; Contains: 00885380114536; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100613

FDA Product Code

• FRO: Dressing, wound, drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-19
• Device Publish Date: 2019-04-11

On-Brand Devices [CARDINAL HEALTH ESSENTIALS]

• 50885380114531: Wound and Skin Cleanser; 16 FL OZ
• 50885380114524: Wound and Skin Cleanser; 12 FL OZ
• 50885380114517: Wound and Skin Cleanser; 8 FL OZ
• 50885380102941: Suction Catheter; Coil Packed 14 Fr
• 50885380102934: Suction Catheter; Coil Packed 12 Fr
• 00888499010232: Suction Catheter; Coil Packed 10 Fr
• 00888499010225: Suction Catheter; Coil Packed 8 Fr
• 00888499010218: Suction Catheter; Straight Packed 18 Fr
• 00888499010201: Suction Catheter; Straight Packed 16 Fr
• 50885380112490: Suction Catheter; Straight Packed 14 Fr
• 00888499010188: Suction Catheter; Straight Packed 12 Fr
• 50885380111806: Suction Catheter; Straight Packed 10 Fr
• 00888499010164: Suction Catheter; Straight Packed 8 Fr
• 50885380112438: Suction Catheter; Straight Packed 6 Fr