FDA.reportPublic FDA data

Albahealth

Primary DI
50073614755852
Brand
Albahealth
Company
Albahealth, LLC
Model
053558C22100304
Device description
NEW PULSTAR WRAP
Published
2016-09-24
Public version status
Update
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
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
50073614755852PackageGS110In Commercial Distribution
00073614755857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5007361475585250073614755852
00073614755857000736147558570736147558570073614755857

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
003375805
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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50885380194632KendallCardinal Health 200, LLCJOW2026-07-31
50885380194649KendallCardinal Health 200, LLCJOW2026-07-31
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50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31
50885380194694KendallCardinal Health 200, LLCJOW2026-07-31
10888277348226MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-29
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