Invia Foam Dressing Kit

Basic Information

• Brand Name: Invia Foam Dressing Kit
• Primary DI: 07612367050005
• Version / Model: 200.8905
• Company Name: Medela AG
• Labeler DUNS: 488293218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-07
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 56860bc1-832a-429e-85d0-8bdb3b90e75d

Device Description

Invia Foam Dressing Kit with Fitpad - Small Sales number: 087.6221 3 PCs / 087.6225 15 pcs

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: No
• 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: 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
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
Package	07612367050029	GS1		15	In Commercial Distribution
Primary	07612367050005	GS1
Package	07612367050012	GS1		3	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K170088	000