FDA.reportPublic FDA data

ALP®

Primary DI
00857910006512
Brand
ALP®
Company
CURRIE MEDICAL SPECIALTIES INC.
Model
ALP® 1A CALF-R
Catalog number
500003
Device description
ALP 1A CALF-R - Garment (Calf, 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
00857910006512PackageGS120In Commercial Distribution
00857910006017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857910006512008579100065128579100065120857910006512
00857910006017008579100060178579100060170857910006017

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent venous compression system pumpAn electrically-powered device used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit with the necessary pressure to promote venous blood flow. This is achieved through the cyclical inflation and deflation of a single-chambered stocking/sleeve/suit applied to the extremities. It typically consists of a compressor with control/timing mechanism, pressure limiting device, tubing, and connectors. 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.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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