FDA.reportPublic FDA data

HARVEST® AdiPrep®

Primary DI
05020583514331
Brand
HARVEST® AdiPrep®
Company
TERUMO BCT, INC.
Model
51433
Device description
ADI-25-03 Adipose Procedure Pack
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUUSystem, suction, lipoplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUUSystem, Suction, LipoplastyGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121005000ADIPREP ADIPOSE TRANSFER SYSTEMHarvest Technologies, Corp.2012-09-21MUU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05020583514331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05020583514331050205835143315020583514331

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 Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)339-4228FDAUDIprogram@terumobct.com

Regulatory Flags#

DUNS number
801679200
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05020583103108Spectra Optia®103102016-09-15
05020583610002Spectra Optia®610002016-09-15
05020583001145Reveos® Automated Whole Blood Processing System240002025-08-06
05020583826502Trima Accel826502023-06-19
05020583803664Trima Accel® 803662017-02-15
05020583804005Trima Accel®804002016-09-15
05020583824089Trima Accel® 824082016-09-15
05020583826601Trima Accel® 826602016-09-15
05020583826663Trima Accel® 826662017-02-15
05020583700512Blood Component Sampling Sets700512016-09-15
05020583803565Trima Accel® 803562017-02-15
05020583804401Trima Accel® 804402016-09-15
05020583824409Trima Accel® 824402016-09-15
05020583803503Trima Accel® 803502016-09-15
05020583803701Trima Accel® 803702016-09-15
05020583803404Trima Accel® 803402016-09-15
05020583803602Trima Accel® 803602016-09-15
05020583807006Trima Accel® 807002016-09-15
05020583804500Trima Accel® 804502016-09-15
05020583805002Trima Accel® 805002016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130455843Medco ManufacturingMedco Manufacturing LLCMUU2026-03-31
04260632793640TLA Tubing Liposat Pro plusMöller Medical GmbHMUU2026-02-27
04260632794043TLA Tubing Liposat Pro plusMöller Medical GmbHMUU2026-02-27
00850000712478Autoclavable Suction Jar with Hose Barb extension - 250mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712485Autoclavable Suction Jar with Hose Barb extension - 500mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712492Autoclavable Suction Jar with Hose Barb extension - 1000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712508Autoclavable Suction Jar with Hose Barb extension - 2000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712515Autoclavable Suction Jar with Hose Barb extension - 3000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00810130455812Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455829Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455485Medco ManufacturingMedco Manufacturing LLCMUU2025-09-11
00810130455195Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
00810130455201Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
08800052308909FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
08800052308886FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
08800052316904FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
00810130454839Medco ManufacturingMedco Manufacturing LLCMUU2025-02-27
00385640084987SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640084994SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085007SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085014SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085021SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGMUU2024-05-31
07612367003551Quiver 280mmMedela AGMUU2024-05-31
07612367003568Quiver 480mmMedela AGMUU2024-05-31
07612367003698Overflow protection deviceMedela AGMUU2024-05-31
07612367003735Reusable serial connectorMedela AGMUU2024-05-31
07612367003742Safety Set for railholderMedela AGMUU2024-05-31
07612367003896Tubing holder left sideMedela AGMUU2024-05-31
07612367003902Tubing holder right sideMedela AGMUU2024-05-31