N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00885825015657
• Version / Model: N/A
• Catalog Number: 5480
• Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.
• Labeler DUNS: 020198912
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a57cfd7a-7d0a-41aa-a06f-e0bb2e2729b0

Device Description

Compression Sleeve Thigh

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: No
• 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
61810	Multi-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 sequential inflation of several chambers. 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	50885825015652	GS1	case	5	In Commercial Distribution
Primary	00885825015657	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100909	000

Device Sizes

Type	Value	Unit	Text
Circumference	36.0	Inch