101593

GUDID 37332414010868

SP-C13 Accessory spike

GAMBRO DASCO SPA

Haemodialysis blood tubing set, single-use

• Primary Device ID: 37332414010868
• NIH Device Record Key: 00beb62a-2520-4345-acf2-c637f4e27b8e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6038020
• Catalog Number: 101593
• Company DUNS: 428788780
• Company Name: GAMBRO DASCO SPA
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees 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 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored in a dry place. Keep dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332414010867 [Primary]
GS1	37332414010868 [Package]; Contains: 07332414010867; Package: CASE [75 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823707

FDA Product Code

• KOC: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-10-28

Devices Manufactured by GAMBRO DASCO SPA

• 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: 2019-06-07SP-C13 Accessory spike
• 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