FDA.reportPublic FDA data

RE-CUR PVA/ALP®

Primary DI
00857910006840
Brand
RE-CUR PVA/ALP®
Company
CURRIE MEDICAL SPECIALTIES INC.
Model
RE-CUR PVA/ALP®2
Catalog number
500013R
Device description
RE-CUR PVA/ALP®2 - Garment (Reprocessed, Foot, Adult)
Published
2019-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00857910006840PackageGS120In Commercial Distribution
00857910006345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857910006840008579100068408579100068400857910006840
00857910006345008579100063458579100063450857910006345

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079598595
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857910006512ALP®ALP® 1A CALF-R5000032019-07-26
00857910006529ALP®ALP® 2 CALF-L5000042019-07-26
00857910006543ALP®ALP® 2 CALF-XL5000102019-07-26
00857910006567ALP®ALP® 2 CALF XXL5000162019-07-26
00857910006581ALP®ALP® 1P5000192019-07-26
00857910006598ALP®ALP® 3 THIGH-R5000062019-07-26
00857910006604ALP®ALP® 4 THIGH-L5000082019-07-26
00857910006611ALP® ALP® 3 SM THIGH5000092019-07-26
00857910006635ALP®MS/PVA ALP®15000122019-07-26
00857910006703RE-CUR ALP®RE-CUR ALP® 1 CALF-R500002R2019-07-26
00857910006710RE-CUR ALP®RE-CUR ALP® 1A CALF - R500004R2019-07-26
00857910006727RE-CUR ALP® RE-CUR ALP® 2 CALF-L500004R2019-07-26
00857910006741RE-CUR ALP®RE-CUR ALP® 2 CALF-XL500010R2019-07-26
00857910006758RE-CUR ALP®RE-CUR ALP® 1 CALF-S R500015R2019-07-26
00857910006796RE-CUR ALP®RE-CUR ALP® 3 THIGH-R500006R2019-07-26
00857910006802RE-CUR ALP®RE-CUR ALP® 4 THIGH-L500008R2019-07-26
00857910006819RE-CUR ALP®RE-CUR ALP® 3 SM THIGH500009R2019-07-26
00857910006833RE-CUR PVA/ALP®RE-CUR PVA/ALP®1500012R2019-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
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