FDA.reportPublic FDA data

ALP® 900

Primary DI
00857910006994
Brand
ALP® 900
Company
CURRIE MEDICAL INC.
Model
ALP® 900 Pump
Catalog number
600900
Device description
ALP® 900 Pump
Published
2024-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K231801000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231801000MedHealth DVT compression Devices MHH900S/MHH900EMedhealth Medical Limited2023-12-14JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857910006991PackageGS14In Commercial Distribution
00857910006994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085791000699110857910006991
00857910006994008579100069948579100069940857910006994

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

Contacts#

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

Regulatory Flags#

DUNS number
124096353
Device count
1
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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