AccessGUDID - DEVICE: HARVEST® AdiPrep® (05020583514331)

GUDID

Device Identifier (DI) Information

Brand Name: HARVEST® AdiPrep®
Version or Model: 51433
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TERUMO BCT, INC.

Primary DI Number: 05020583514331
Issuing Agency: GS1
Commercial Distribution End Date: November 15, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 801679200 *Terms of Use

Device Description: ADI-25-03 Adipose Procedure Pack

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36894	Liposuction system	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUU	System, suction, lipoplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 930edae2-32c9-4477-965f-c5da251589d7
Public Version Date: February 08, 2024
Public Version Number: 10
DI Record Publish Date: September 15, 2016