FDA.reportPublic FDA data

RE-CUR ALP®

Primary DI
00857910006314
Brand
RE-CUR ALP®
Company
Cavalier Alp, LLC
Model
RE-CUR ALP® 3 SM THIGH
Catalog number
500009R
Device description
RE-CUR ALP® 3 SM THIGH - Garment (Reprocessed, Thigh, Adult)
Published
2019-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140092000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140092000CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)Currie Medical Specialties, Inc.2014-04-16JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857910006819PackageGS120In Commercial Distribution
00857910006314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857910006819008579100068198579100068190857910006819
00857910006314008579100063148579100063140857910006314

GMDN Terms#

Term, Definition table
TermDefinition
Single-chamber venous compression system garment, reprocessedA 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.

Regulatory Flags#

DUNS number
105514832
Device count
1
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857910006017ALP®ALP® 1A CALF-R5000032019-07-26
00857910006024ALP®ALP® 2 CALF-L5000042019-07-26
00857910006048ALP®ALP® 2 CALF-XL5000102019-07-26
00857910006062ALP®ALP® 2 CALF XXL5000162019-07-26
00857910006086ALP®ALP® 1P5000192019-07-26
00857910006093ALP®ALP® 3 THIGH-R5000062019-07-26
00857910006109ALP®ALP® 4 THIGH-L5000082019-07-26
00857910006116ALP® ALP® 3 SM THIGH5000092019-07-26
00857910006130ALP®MS/PVA ALP®15000122019-07-26
00857910006147ALP®MS/PVA ALP®25000132024-01-31
00857910006208RE-CUR ALP®RE-CUR ALP® 1 CALF-R500002R2019-07-26
00857910006215RE-CUR ALP®RE-CUR ALP® 1A CALF - R500003R2019-07-26
00857910006222RE-CUR ALP® RE-CUR ALP® 2 CALF-L500004R2019-07-26
00857910006246RE-CUR ALP®RE-CUR ALP® 2 CALF-XL500010R2019-07-26
00857910006253RE-CUR ALP®RE-CUR ALP® 1 CALF-S R500015R2019-07-26
00857910006291RE-CUR ALP®RE-CUR ALP® 3 THIGH-R500006R2019-07-26
00857910006307RE-CUR ALP®RE-CUR ALP® 4 THIGH-L500008R2019-07-26
00857910006338RE-CUR PVA/ALP®RE-CUR PVA/ALP®1500012R2019-07-26
00857910006345RE-CUR PVA/ALP®RE-CUR PVA/ALP®2500013R2019-07-26
00857910006000ALP®ALP® 1 CALF-R5000022019-07-26

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