REPEATER

Basic Information

• Brand Name: REPEATER
• Primary DI: 00085412482521
• Version / Model: H938099E
• Catalog Number: H938099E
• Company Name: BAXTER HEALTHCARE CORPORATION
• Labeler DUNS: 005083209
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2023-07-21
• Public Version Status: Update
• Public Device Record Key: c01a2afa-f256-4b9e-a970-071c5721f40b

Device Description

REPEATER Pump, Fluid Transfer Pump

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEP	SYSTEM/DEVICE, PHARMACY COMPOUNDING	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17459	Intravenous solution compounder	A device that is typically exclusively used in the clinical pharmacy or a manufacturing plant for the production of intravenous (IV) fluids. These fluids will typically be distributed using the appropriate containers.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00085412482521	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 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
• Type: Handling Environment Temperature
• Temperature Range: 41 – 104 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 32 – 147.2 Degrees Fahrenheit