ALP®

Basic Information

• Brand Name: ALP®
• Primary DI: 00857910006116
• Version / Model: ALP® 3 SM THIGH
• Catalog Number: 500009
• Company Name: Cavalier Alp, LLC
• Labeler DUNS: 105514832
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-26
• Public Version: 2
• Public Version Date: 2024-01-30
• Public Version Status: Update
• Public Device Record Key: e545e1f8-76eb-414f-b9ec-b8b98876c69d

Device Description

ALP® 3 SM THIGH - Garment (Thigh, Adult)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: Yes
• 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
44769	Single-chamber venous compression system garment, single-use	An 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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00857910006611	GS1	Case 10 pr	20	In Commercial Distribution
Primary	00857910006116	GS1

Premarket Submissions

Submission Number	Supplement Number
K955853	000