FDA.reportPublic FDA data

MICROTEK

Primary DI
50748426046947
Brand
MICROTEK
Company
Microtek Medical Inc.
Model
1
Device description
5'' AIR TUBING ASSY (MODEL 610), 1-EACH
Published
2016-11-04
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

Contact Domains#

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
50748426046947PackageGS15In Commercial Distribution
00748426046942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074842604694750748426046947
00748426046942007484260469427484260469420748426046942

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent venous compression system pumpAn electrically-powered device used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit with the necessary pressure to promote venous blood flow. This is achieved through the cyclical inflation and deflation of a single-chambered stocking/sleeve/suit applied to the extremities. It typically consists of a compressor with control/timing mechanism, pressure limiting device, tubing, and connectors. 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store under normal warehouse conditions.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)824-3027customerservicemicrotekmed.com@ecolab.com

Regulatory Flags#

DUNS number
106908437
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
10748426134806VELYS™Equipment Drapes4516-11-0182025-01-24
10748426134813VELYS™Equipment Drapes4516-11-0192025-01-24
10748426134820VELYS™Equipment Drapes4516-11-0202025-01-24
10748426137104MedtronicEquipment Drapes97327222024-11-05
10748426137111MedtronicEquipment Drapes97330232024-11-05
10748426137203Boston ScientificProbe Cover (BSC 3320)6633202024-10-22
50748426123976Zimmer BiometEquipment Drapes20-8020-080-002024-10-15
30748426123569Cardinal HealthOrgan Bag29-100392024-09-26
50748426113748EcolabCoreTemp EquipmentCTW5L2023-11-30
50748426126731EcolabHush Slush EquipmentESW7L2023-11-16
08425921000502MICROTEK12018-08-29
18425921000530MICROTEK12018-08-29
18425921000578MICROTEK12018-08-29
18425921000592MICROTEK12018-08-29
18425921000615MICROTEK12018-08-29
18425921000639MICROTEK12018-08-29
00748426130092DePuy Synthes VELYS4515700184515-70-0182023-03-09
50748426130110DePuy Synthes VELYS4515700194515-70-0192023-03-09
30748426074946Microtek™9604UK9604UK2022-09-21
30748426132196CovidienPC-6X96PC-6X962022-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00850001096546Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096553Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
10885380185120KendallCardinal Health 200, LLCJOW2026-02-10
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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
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