FDA.reportPublic FDA data

"Tubing for tumescent pump ""Liposat"""

Primary DI
04260277175870
Brand
"Tubing for tumescent pump ""Liposat"""
Company
Möller Medical GmbH
Model
00002251
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
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
K053451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053451000LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V);Moeller Medical GmbH & Co. KG2006-08-25QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260277175887PackageGS110In Commercial Distribution
04260277175894PackageGS1120In Commercial Distribution
04260277175870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260277175887042602771758874260277175887
04260277175894042602771758944260277175894
04260277175870042602771758704260277175870

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
320405061
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260632793640TLA Tubing Liposat Pro plus000039972026-02-27
04260632794043TLA Tubing Liposat Pro plus000039972026-02-27
04260632792339TLA Tubing Liposat Pro plus000039972020-01-21
04260277172831Breast localisation needleBLM-1110-20-00302018-08-17
04260277172848Breast localisation needleBLM-1110-20-00502018-08-17
04260277172862Breast localisation needleBLM-1110-20-01002018-12-10
04260632791622Basket Cannula 2.0ASC-R520-30-02502019-05-09
04260632791639Basket Cannula 2.0ASC-R520-30-03502019-05-09
04260632791646Basket Cannula 2.0ASC-R520-40-02502019-05-09
04260632791660Basket Cannula 2.0ASC-R520-50-02502019-05-09
04260632791677Basket Cannula 2.0ASC-R520-50-03502019-05-09
04260632791684Basket Cannula 2.0ASC-R521-30-02502019-05-09
04260632791691Basket Cannula 2.0ASC-R521-30-03502019-05-09
04260632791707Basket Cannula 2.0ASC-R521-40-02502019-05-09
04260632791721Basket Cannula 2.0ASC-R521-50-02502019-05-09
04260632790151Basket Cannula 2.0ASC-S520-40-03502019-05-06
04260632790168Basket Cannula 2.0ASC-S520-50-02502019-05-06
04260632790175Basket Cannula 2.0ASC-S520-50-03502019-05-06
04260632790182Basket Cannula 2.0ASC-S521-30-02502019-05-06
04260632790205Basket Cannula 2.0ASC-S521-40-02502019-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329838225BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.QPB2026-06-08
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGMUU2024-05-31
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGQPB2024-05-31
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 AGQPB2024-05-31
07612367003698Overflow protection deviceMedela AGMUU2024-05-31
07612367003735Reusable serial connectorMedela AGQPB2024-05-31
07612367003735Reusable serial connectorMedela AGMUU2024-05-31
07612367003742Safety Set for railholderMedela AGQPB2024-05-31
07612367003742Safety Set for railholderMedela AGMUU2024-05-31
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 AGMUU2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGQPB2024-05-31
07612367004688Holder for 1L/1.5L jar, leftMedela AGQPB2024-05-31
07612367004688Holder for 1L/1.5L jar, leftMedela AGMUU2024-05-31
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 AGMUU2024-05-31
07612367004701Holder for 2L/2.5L jar, leftMedela AGQPB2024-05-31
07612367004718Holder for 2L/2.5L jar, rightMedela AGQPB2024-05-31
07612367004718Holder for 2L/2.5L jar, rightMedela AGMUU2024-05-31
07612367008242Double conical coupling pieceMedela AGMUU2024-05-31
07612367008242Double conical coupling pieceMedela AGQPB2024-05-31