NPseal Large

Basic Information

• Brand Name: NPseal Large
• Primary DI: 10860004811333
• Version / Model: GM01-003
• Company Name: Guard Medical Inc.
• Labeler DUNS: 118095992
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-08-31
• Public Version: 1
• Public Version Date: 2022-09-08
• Public Version Status: New
• Public Device Record Key: f739a36b-4582-491d-ae66-ef4a311fd685

Device Description

NPseal Large Advanced Negative Pressure Dressing (box of 10, Large)

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: MR Unsafe
• 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
OKO	Negative Pressure Wound Therapy Non-Powered Suction Apparatus	General, Plastic Surgery	878.4683	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47406	Negative-pressure wound therapy system foam dressing, non-antimicrobial	A pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure, commonly known as negative pressure wound therapy (NPWT); it does not include an antimicrobial agent(s). It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00860004811336	GS1
Primary	10860004811333	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K212971	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 23 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from moisture during storage