FDA.reportPublic FDA data

Albahealth

Primary DI
50073614762157
Brand
Albahealth
Company
Albahealth, LLC
Model
053558G22100304
Device description
NEW PULSTAR ANTI-EMBOLISM 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
50073614762157PackageGS110In Commercial Distribution
00073614762152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5007361476215750073614762157
00073614762152000736147621520736147621520073614762152

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257188422MEDIMEDI MANUFACTURING, INC.JOW2026-10-27
00636257221785MEDIMEDI MANUFACTURING, INC.JOW2026-10-27
00636257221792MEDIMEDI MANUFACTURING, INC.JOW2026-10-27
00850078826213BioTAB LLCBiotab LLCJOW2026-10-26
00850078826220BioTAB LLCBiotab LLCJOW2026-10-26
00850078826237BioTAB LLCBiotab LLCJOW2026-10-26
00850078826244BioTAB LLCBiotab LLCJOW2026-10-26
00850078826251BioTAB LLCBiotab LLCJOW2026-10-26
00850078826268BioTAB LLCBiotab LLCJOW2026-10-26
00850078826275BioTAB LLCBiotab LLCJOW2026-10-26
00850078826282BioTAB LLCBiotab LLCJOW2026-10-26
00850078826299BioTAB LLCBiotab LLCJOW2026-10-26
00850078826305BioTAB LLCBiotab LLCJOW2026-10-26
00850078826312BioTAB LLCBiotab LLCJOW2026-10-26
00850078826329BioTAB LLCBiotab LLCJOW2026-10-26
00850031012769AIROSAIROS MEDICAL INCJOW2026-10-09
00812311022448Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
00812311022486Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
00190446979128AIRCASTDJO, LLCJOW2026-08-03
50885380194564KendallCardinal Health 200, LLCJOW2026-07-31
50885380194571KendallCardinal Health 200, LLCJOW2026-07-31
50885380194588KendallCardinal Health 200, LLCJOW2026-07-31
50885380194601KendallCardinal Health 200, LLCJOW2026-07-31
50885380194618KendallCardinal Health 200, LLCJOW2026-07-31
50885380194625KendallCardinal Health 200, LLCJOW2026-07-31
50885380194632KendallCardinal Health 200, LLCJOW2026-07-31
50885380194649KendallCardinal Health 200, LLCJOW2026-07-31
50885380194656KendallCardinal Health 200, LLCJOW2026-07-31
50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31