FDA.reportPublic FDA data

MicroAire®

Primary DI
00847399006554
Brand
MicroAire®
Company
Microaire Surgical Instruments LLC
Model
ASP-RNG-1200
Published
2016-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MUUSystem, Suction, Lipoplasty
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUUSystem, Suction, LipoplastyGeneral, Plastic Surgery2
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113128000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113128000MICROAIRE SURGICAL INSTRUMENTS LLCMicroaire Surgical Instruments, LLC2012-08-17QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847399006554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847399006554008473990065548473990065540847399006554

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction systemAn assembly of devices designed specifically to aspirate subcutaneous fat from the body by means of suction during a liposuction/lipectomy procedure. The system consists of an electrically-powered suction pump, typically with collection containers, tubing, and microbial/hydrophobic filters, and includes patient contact devices (e.g., handpiece/tip, cannula). The pump generates negative pressure for aspiration of fat through the patient contact device, which is inserted subcutaneously into the fat layer, and into the collection containers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103056420
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847399003591MicroAire® 2500-1002022-02-07
00847399003607MicroAire® 2500-2002022-02-07
00847399017406MicroAire®CART-CLAMP2025-08-01
00847399017413MicroAire® 70202025-08-01
00847399017420MicroAire® 7020-PAL2025-08-01
00847399017437MicroAire®5020-ASP2025-08-01
00847399017444MicroAire®7020-ASP2025-08-01
00847399017451MicroAire®7020-INF2025-08-01
00847399017468MicroAire®7020-PEDAL2025-08-01
00847399017475MicroAire® ASP-PUMP-1202025-08-01
00847399017482MicroAire® ASP-UI2025-08-01
00847399017499MicroAire® ASP-CBL2025-08-01
00847399017505MicroAire®ASP-FOOT2025-08-01
00847399017512MicroAire®ASP-FLTR22025-08-01
00847399017536MicroAire®CART2025-08-01
00847399017543MicroAire®CART-RING2025-08-01
00847399017550MicroAire®CART-IV-POLE2025-08-01
00847399018960MicroAire®ASP-TUBING2025-08-01
00847399019004MicroAire®CART-POLE2025-08-01
00847399019011MicroAire®CART-BASKET2025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGQPB2024-05-31
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGMUU2024-05-31
07612367003551Quiver 280mmMedela AGMUU2024-05-31
07612367003551Quiver 280mmMedela AGQPB2024-05-31
07612367003568Quiver 480mmMedela AGMUU2024-05-31
07612367003568Quiver 480mmMedela AGQPB2024-05-31
07612367003575Change over valveMedela AGQPB2024-05-31
07612367003698Overflow protection deviceMedela AGMUU2024-05-31
07612367003698Overflow protection deviceMedela AGQPB2024-05-31
07612367003735Reusable serial connectorMedela AGQPB2024-05-31
07612367003735Reusable serial connectorMedela AGMUU2024-05-31
07612367003742Safety Set for railholderMedela AGMUU2024-05-31
07612367003742Safety Set for railholderMedela AGQPB2024-05-31
07612367003896Tubing holder left sideMedela AGQPB2024-05-31
07612367003896Tubing holder left sideMedela AGMUU2024-05-31
07612367003902Tubing holder right sideMedela AGQPB2024-05-31
07612367003902Tubing holder right sideMedela AGMUU2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGQPB2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGMUU2024-05-31
07612367004688Holder for 1L/1.5L jar, leftMedela AGMUU2024-05-31
07612367004688Holder for 1L/1.5L jar, leftMedela AGQPB2024-05-31
07612367004695Holder for 1L/1.5L jar, rightMedela AGQPB2024-05-31
07612367004695Holder for 1L/1.5L jar, rightMedela AGMUU2024-05-31
07612367004701Holder for 2L/2.5L jar, leftMedela AGQPB2024-05-31
07612367004701Holder for 2L/2.5L jar, leftMedela AGMUU2024-05-31
07612367004718Holder for 2L/2.5L jar, rightMedela AGQPB2024-05-31
07612367004718Holder for 2L/2.5L jar, rightMedela AGMUU2024-05-31
07612367008242Double conical coupling pieceMedela AGQPB2024-05-31
07612367008242Double conical coupling pieceMedela AGMUU2024-05-31
07612367008655Silicone tube, ID 7mm, 33cmMedela AGMUU2024-05-31