FDA.reportPublic FDA data

ALP®

Primary DI
00857910006635
Brand
ALP®
Company
CURRIE MEDICAL SPECIALTIES INC.
Model
MS/PVA ALP®1
Catalog number
500012
Device description
MS/PVA ALP®1 - Garment (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
true

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
K964188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964188000HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENTHealthcare Service and Supply1997-05-06JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857910006635PackageGS120In Commercial Distribution
00857910006130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857910006635008579100066358579100066350857910006635
00857910006130008579100061308579100061300857910006130

GMDN Terms#

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

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
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
00857910006840RE-CUR PVA/ALP®RE-CUR PVA/ALP®2500013R2019-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446979128AIRCASTDJO, LLCJOW2026-08-03
50885380194564KendallCardinal Health 200, LLCJOW2026-07-31
50885380194571KendallCardinal Health 200, LLCJOW2026-07-31
50885380194588KendallCardinal Health 200, LLCJOW2026-07-31
50885380194601KendallCardinal Health 200, LLCJOW2026-07-31
50885380194618KendallCardinal Health 200, LLCJOW2026-07-31
50885380194625KendallCardinal Health 200, LLCJOW2026-07-31
50885380194632KendallCardinal Health 200, LLCJOW2026-07-31
50885380194649KendallCardinal Health 200, LLCJOW2026-07-31
50885380194656KendallCardinal Health 200, LLCJOW2026-07-31
50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31
50885380194694KendallCardinal Health 200, LLCJOW2026-07-31
10888277348226MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-29
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
10888277348141MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
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