NA

Basic Information

• Brand Name: NA
• Primary DI: 10888551004978
• Version / Model: AIR3040
• Catalog Number: AIR3040
• Company Name: STERILMED, INC.
• Labeler DUNS: 175899459
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 5
• Public Version Date: 2019-04-17
• Public Version Status: Update
• Public Device Record Key: c47dde33-13e6-4e50-939a-458173e6c838
• Distribution End Date: 2019-04-17

Device Description

DVT GARMENT VENAFLOW ELITE STANDARD CALF CUFF

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOW	SLEEVE, LIMB, COMPRESSIBLE	Cardiovascular	870.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61809	Single-chamber venous compression system garment, reprocessed	A non-sterile, inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the intermittent inflation of a single-chamber. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a previously used single-use device that has been processed for an additional single-use patient application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20888551004975	GS1	Carton	5	Not in Commercial Distribution	2019-04-17
Primary	10888551004978	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K012597	000