FDA.reportPublic FDA data

ArtAssist

Primary DI
00860446000305
Brand
ArtAssist
Company
ACI MEDICAL LLC
Model
AA-1000
Catalog number
AA-1000
Device description
Limb compression device with automatic pressure cycling.
Published
2016-09-24
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
K131146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131146000ARTASSIST AND VENASSISTAci Medical, LLC2014-02-10JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860446000305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860446000305008604460003058604460003050860446000305

GMDN Terms#

Term, Definition table
TermDefinition
Single-chamber venous compression system garment, reusableAn inflatable device in the form of a stocking, sleeve, or suit that is 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 reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7607444400info@acimedical.com

Regulatory Flags#

DUNS number
153761499
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860446000336FlowDynFD12023-06-15
00860446000329VenaPulseVP-25VP-252016-09-24
00860446000312APG Air-PlethysmographAPG-1000APG-10002016-09-24

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Primary DI, Brand, Company table
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