107650

GUDID 37332414075829

SP 418 (9L Bag) Accessory Drain Bag

GAMBRO DASCO SPA

Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag

• Primary Device ID: 37332414075829
• NIH Device Record Key: c28c6df6-bb6c-4928-ab9b-aff64e2385dd
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6033765
• Catalog Number: 107650
• Company DUNS: 428788780
• Company Name: GAMBRO DASCO SPA
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com

Device Dimensions

• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter
• Total Volume: 9 Liter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use 20 degree Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332414075828 [Primary]
GS1	37332414075829 [Package]; Contains: 07332414075828; Package: CASE [30 Units]; In Commercial Distribution

FDA Product Code

• MON: SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-09
• Device Publish Date: 2021-07-30

Devices Manufactured by GAMBRO DASCO SPA

• 37332414075829 - NA: 2021-08-09SP 418 (9L Bag) Accessory Drain Bag
• 37332414075829 - NA: 2021-08-09 SP 418 (9L Bag) Accessory Drain Bag
• 37332414004690 - NA: 2019-06-07 S-660-C Accessory Y connector
• 37332414010868 - NA: 2019-06-07 SP-C13 Accessory spike
• 37332414032532 - NA: 2019-06-07 SP-394 Accessory reinfusion line
• 37332414044733 - NA: 2019-06-07 SP-390 Accessory adaptor
• 37332414048915 - NA: 2019-06-07 GMB-SP127 Accessory Y connector
• 37332414075430 - NA: 2019-06-07 SP-420 Accessory extension line
• 07332414106119 - EXALIS: 2018-12-17 Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This softwa