FDA.reportPublic FDA data

Albahealth

Primary DI
00073614779983
Brand
Albahealth
Company
Albahealth, LLC
Model
BLL500032100304
Device description
LEGACY LOGIX CALF SLEEVE xLARG
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K123308000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123308000PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEMAlbahealth, LLC2013-02-08JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50073614779988PackageGS124In Commercial Distribution
00073614779983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5007361477998850073614779988
00073614779983000736147799830736147799830073614779983

GMDN Terms#

Term, Definition table
TermDefinition
Multi-chamber venous compression system garment, single-useA non-sterile, 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 sequential inflation of several chambers. 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.

Regulatory Flags#

DUNS number
003375805
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00073614702226AlbahealthCN50120099909022016-09-22
00073614702271Albahealth0N54080099909022016-09-22
00073614702356AlbahealthCN54120099909022016-09-22
00073614702462Albahealth0N55060099909022016-09-22
00073614702509Albahealth0N55070099909022016-09-22
00073614702554Albahealth0N55080099909022016-09-22
00073614702615AlbahealthCN55090099909022016-09-22
00073614702691AlbahealthCN55120099909022019-03-01
00073614702738Albahealth0N55180099909022016-09-22
00073614702790Albahealth0N55300099909022016-09-22
00073614702851AlbahealthCN55360099909022019-03-01
00073614702899Albahealth0N55640099909022016-09-22
00073614706149Albahealth0T50120099909022016-09-22
00073614706163AlbahealthCT54120099909022016-09-22
00073614706200Albahealth0T55090099909022016-09-22
00073614706224Albahealth0T55120099909022016-09-22
00073614709447AlbahealthC010480099903042016-09-22
00073614710924AlbahealthC206300099903042019-03-01
00073614710948AlbahealthC208380099903042016-09-22
00073614710979AlbahealthC210480099903042016-09-22

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