FDA.reportPublic FDA data

Revolve ENVI 600 Advanced Adipose System

Primary DI
M328RV0001E6000
Brand
Revolve ENVI 600 Advanced Adipose System
Company
LIFECELL CORPORATION
Model
RV0001E600
Catalog number
RV0001E600
Device description
Tissue Processing System
Published
2017-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
K163647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163647000Revolve Envi 600 Advanced Adipose SystemLifecell Corporation2017-08-25MUU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818410012410PrimaryGS10
M328RV0001E6000SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818410012410008184100124108184100124100818410012410

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA cylindrical or bottle-shaped sealable container intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
157224205
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M32802040040Conexa Reconstructive Tissue Matrix020400402040042015-09-17
M32803030030Conexa Reconstructive Tissue Matrix030300303030032015-09-17
M32804040040Conexa Reconstructive Tissue Matrix040400404040042015-09-17
M32805050030Conexa Reconstructive Tissue Matrix050500305050032015-09-17
M32805100030Conexa Reconstructive Tissue Matrix051000305100032015-09-17
M32805100040Conexa Reconstructive Tissue Matrix051000405100042015-09-17
M32806060040Conexa Reconstructive Tissue Matrix060600406060042015-09-17
M32803140060Strattice Reconstructive Tissue Matrix BPS031400603140062015-09-17
M32804160060Strattice Reconstructive Tissue Matrix BPS041600604160062015-09-17
M32805160010Strattice Reconstructive Tissue Matrix051600105160012015-09-17
M32806060020Strattice Reconstructive Tissue Matrix060600206060022015-09-17
M32806080010Strattice Reconstructive Tissue Matrix060800106080012015-09-17
M32806080050Strattice Reconstructive Tissue Matrix Laparoscopic060800506080052015-09-17
M32806100080Strattice Reconstructive Tissue Matrix061000806100082015-09-17
M32806130090Strattice Reconstructive Tissue Matrix061300906130092015-09-17
M32806160020Strattice Reconstructive Tissue Matrix061600206160022015-09-17
M328061610970ARTIA Reconstructive Tissue Matrix06161097061610972016-10-28
M32808080020Strattice Reconstructive Tissue Matrix080800208080022015-09-17
M32808080060Strattice Reconstructive Tissue Matrix BPS080800608080062015-09-17
M32808150090Strattice Reconstructive Tissue Matrix081500908150092015-09-17

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