FDA.reportPublic FDA data

ALP®

Primary DI
00857910006642
Brand
ALP®
Company
Cavalier Alp, LLC
Model
MS/PVA ALP®2
Catalog number
500013
Device description
MS/PVA ALP®2 - Garment (Foot, Adult)
Published
2024-01-31
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

Contact Domains#

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
00857910006642PackageGS120In Commercial Distribution
00857910006147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857910006642008579100066428579100066420857910006642
00857910006147008579100061478579100061470857910006147

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

Contacts#

Phone, Email table
PhoneEmail
800-669-3521cservice@curriemedical.com

Regulatory Flags#

DUNS number
105514832
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
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
00857910006314RE-CUR ALP®RE-CUR ALP® 3 SM THIGH500009R2019-07-26
00857910006338RE-CUR PVA/ALP®RE-CUR PVA/ALP®1500012R2019-07-26
00857910006345RE-CUR PVA/ALP®RE-CUR PVA/ALP®2500013R2019-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257188422MEDIMEDI MANUFACTURING, INC.JOW2026-10-27
00636257221785MEDIMEDI MANUFACTURING, INC.JOW2026-10-27
00636257221792MEDIMEDI MANUFACTURING, INC.JOW2026-10-27
00850078826213BioTAB LLCBiotab LLCJOW2026-10-26
00850078826220BioTAB LLCBiotab LLCJOW2026-10-26
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00850078826244BioTAB LLCBiotab LLCJOW2026-10-26
00850078826251BioTAB LLCBiotab LLCJOW2026-10-26
00850078826268BioTAB LLCBiotab LLCJOW2026-10-26
00850078826275BioTAB LLCBiotab LLCJOW2026-10-26
00850078826282BioTAB LLCBiotab LLCJOW2026-10-26
00850078826299BioTAB LLCBiotab LLCJOW2026-10-26
00850078826305BioTAB LLCBiotab LLCJOW2026-10-26
00850078826312BioTAB LLCBiotab LLCJOW2026-10-26
00850078826329BioTAB LLCBiotab LLCJOW2026-10-26
00850031012769AIROSAIROS MEDICAL INCJOW2026-10-09
00812311022448Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
00812311022486Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
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