REPEATER H938099E

GUDID 00085412482521

REPEATER Pump, Fluid Transfer Pump

BAXTER HEALTHCARE CORPORATION

Intravenous solution compounder

• Primary Device ID: 00085412482521
• NIH Device Record Key: c01a2afa-f256-4b9e-a970-071c5721f40b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REPEATER
• Version Model Number: H938099E
• Catalog Number: H938099E
• Company DUNS: 005083209
• Company Name: BAXTER HEALTHCARE CORPORATION
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 147.2 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412482521 [Primary]

FDA Product Code

• NEP: SYSTEM/DEVICE, PHARMACY COMPOUNDING

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: 2020-03-06
• Device Publish Date: 2016-09-23

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