PolyMem

Basic Information

• Brand Name: PolyMem
• Primary DI: 10735471004819
• Version / Model: PolyMem Surgical
• Catalog Number: 0481
• Company Name: FERRIS MFG. CORP.
• Labeler DUNS: 084733682
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 1
• Public Version Date: 2020-09-08
• Public Version Status: New
• Public Device Record Key: c7c44e35-e08f-47dd-ba06-f4811936cb82

Device Description

2.7" x 8.25" PolyMem Surgical Adhesive Film C-Section Dressing

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KMF	Bandage, Liquid	General Hospital	880.5090	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46854	Wound-nonadherent dressing, absorbent, non-antimicrobial	A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20735471004816	GS1	Box	5	In Commercial Distribution
Primary	10735471004819	GS1
Package	30735471004813	GS1	Case	2	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2.7 in. x 8.25 in.

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Excursions permitted less than 55 degrees celcius but should be minimized