Currie Healthcare DVT Sleeve

Basic Information

• Brand Name: Currie Healthcare DVT Sleeve
• Primary DI: 00816317020149
• Version / Model: RM-ALP3
• Company Name: RENU MEDICAL, INC
• Labeler DUNS: 100439103
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-23
• Public Version: 5
• Public Version Date: 2023-09-12
• Public Version Status: Update
• Public Device Record Key: 74fc21ee-5b10-479e-8dba-99150b26c8ca

Device Description

ALP Thigh Length Sleeve-Regular

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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: 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	10816317020146	GS1	CASE	10	In Commercial Distribution
Primary	00816317020149	GS1

Premarket Submissions

Submission Number	Supplement Number
K051227	000