Invia Motion 60 Days Bundle

Basic Information

• Brand Name: Invia Motion 60 Days Bundle
• Primary DI: 10020451454082
• Version / Model: 101045408
• Company Name: Medela LLC
• Labeler DUNS: 052002029
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-20
• Public Version: 2
• Public Version Date: 2024-09-30
• Public Version Status: Update
• Public Device Record Key: 3925d21a-eec9-421c-9957-1045d265f462

Device Description

This new SKU will contain: Motion 60 Days (101011596 / 0874014) - 1x15 pack of medium foam dressings (101011863 / 0876226) - 2x5 packs of motion 150ml canisters (101011598 / 0874016) - 1 return shipping box for the Motion 60 Day (101029404 / 0874004SB).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47404	Negative-pressure wound therapy system canister	A receptacle for the collection of excess interstitial fluid, exudate, and infectious materials from a dedicated dressing that has been applied for a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT). It is typically made of transparent disposable plastic materials and is connected to or placed into the NPWT system's vacuum pump. This receptacle is a single-use device that should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill).	No	Active
47956	Negative-pressure wound therapy system dressing set	A collection of devices that composes a sterile dressing pack used with the pump and collection container of a negative pressure wound therapy (NPWT) system to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers. It typically includes dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, a drain, an evacuation tube, and sterile saline. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10020451454082	GS1