FDA.reportPublic FDA data

AIRCAST

Primary DI
00888912302135
Brand
AIRCAST
Company
DJO, LLC
Model
3004
Device description
PRESSURE VERIFICATION KIT
Published
2016-09-15
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
false

Product Codes#

Code, Name table
CodeName
JOWSLEEVE, LIMB, COMPRESSIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888912302135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912302135008889123021358889123021350888912302135

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent venous compression systemA system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081840873
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446968344DJO SURGICALS-2019632026-03-16
00190446953685DJO SURGICALS-2019592026-02-17
00190446953708DJO SURGICALS-2019582026-02-17
00888912408691DJO SURGICAL800-05-0242023-01-18
00190446940920DJO SURGICALS-2019462025-11-18
00190446660453PROCARE155-81-974272025-07-23
00190446660576PROCARE155-81-971502025-07-23
00190446662686PROCARE155-BH-1942025-07-23
00190446660354PROCARE155-79-843002025-07-14
00190446660583PROCARE155-79-84100C2025-07-14
00190446662785PROCARE155-BH827102025-07-14
00190446662891PROCARE155-81-874802025-07-14
00190446662907PROCARE155-81-874902025-07-14
00190446662914PROCARE155-81-874602025-07-14
00190446662921PROCARE155-81-874702025-07-14
00190446662792PROCARE155-81-873022025-07-11
00190446662808PROCARE155-81-873032025-07-11
00190446662815PROCARE155-81-873052025-07-11
00190446662822PROCARE155-81-873072025-07-11
00190446662839PROCARE155-81-873082025-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719893351026WellellWellell Inc.JOW2026-03-17
00812311022363BIOARTERIAL+Bio Compression Systems, IncJOW2026-03-09
00850033615272ThermoTek WRAP, DVT, CALF SET, PUSH, SPUTHERMOTEK, INC.JOW2026-02-21
00850033615494ThermoTek WRAP,DVT,CA,SET,PUSH,SPU, QTY 10, CTNTHERMOTEK, INC.JOW2026-02-21
00812311022479Bio Arterial DeluxeBio Compression Systems, IncJOW2026-02-13
00850001096386Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096393Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096409Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096416Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096423Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096430Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096447Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096461Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096478Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096485Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096492Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096508Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096522Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096539Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096546Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096553Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
10885380185120KendallCardinal Health 200, LLCJOW2026-02-10
18809802648491DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
18809802648507DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
10816317024427Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
10816317024434Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
10816317024441Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
00850031012615AIROSAIROS MEDICAL INCJOW2026-01-23
10850031012629AIROSAIROS MEDICAL INCJOW2026-01-23
10850031012636AIROSAIROS MEDICAL INCJOW2026-01-23