FDA.reportPublic FDA data

ALP®

Primary DI
00857910006604
Brand
ALP®
Company
CURRIE MEDICAL SPECIALTIES INC.
Model
ALP® 4 THIGH-L
Catalog number
500008
Device description
ALP® 4 THIGH-L - Garment (Thigh, 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
K955853000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955853000HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEMHealthcare Service and Supply1996-06-25JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857910006604PackageGS120In Commercial Distribution
00857910006109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857910006604008579100066048579100066040857910006604
00857910006109008579100061098579100061090857910006109

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
10193489024531MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
04719893351026WellellWellell Inc.JOW2026-03-17
08809802648494DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802648500DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802646810DVT-2600DAESUNG MAREF CO.,LTD.JOW2025-12-19
08809802646858DVT-4000SDAESUNG MAREF CO.,LTD.JOW2025-12-19
10080196138302MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-14
10193489097252MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-13
10192253057775CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057782CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057799CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057805CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057812CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057829CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10193489003154MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-04-17
10193489003161MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-21
10080196391974MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-18
10197344104543MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-03-11
10192253057768CARDINAL HEALTHCardinal Health 200, LLCJOW2025-02-19
10080196385409MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-01-02
10192253016123Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016130Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016185Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10197344098415MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-12-02
10197344006687MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-11-22
10192253057737CARDINAL HEALTHCardinal Health 200, LLCJOW2024-10-02
10885380184895CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184901CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184918CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25