WalkMed®

Basic Information

• Brand Name: WalkMed®
• Primary DI: 00859695006046
• Version / Model: 204820
• Catalog Number: IPR-86
• Company Name: Walkmed Infusion LLC
• Labeler DUNS: 948594726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 9beee4cb-6b7a-4271-a0d7-8f16fffe2d57

Device Description

Pump Reservoir for WalkMed Infusion Pump, 65 mL

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTC	Bag, Reservoir	Anesthesiology	868.5320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35188	Parenteral/enteral solution bag	A flexible pouch or sack designed to contain a solution of nutrients or medication for administration to a patient either parenterally (e.g., intravenously) or enterally (directly into the gastrointestinal tract). It is typically made of synthetic polymer materials. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859695006046	GS1
Package	10859695006043	GS1	Case Package of 10	10	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	65	Milliliter

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -34.4 – 54.4 Degrees Celsius