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

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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
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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
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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