AccessGUDID - DEVICE: Suction jar, 2 ltr (07612367007023)

GUDID

Device Identifier (DI) Information

Brand Name: Suction jar, 2 ltr
Version or Model: 080.0024
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medela AG

Primary DI Number: 07612367007023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 488293218 *Terms of Use

Device Description: Suction jar, polysulfone, 2 l, OKM, K7503763

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":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Suction system canister, reusable	A cylindrical sealable container typically made of hard plastic materials used as a component of a suction system, or other system that utilizes suction, and which is designed for the collection of aspirated waste materials (e.g., blood, bodily fluids, rinsing fluids, laser plume evacuation gas) and/or body tissue intended for diagnostic/therapeutic purposes (e.g., histological analysis, autologous fat tissue transfer) from a site of operation. This device is typically used in conjunction with a dedicated disposable liner that confines and stores the contaminated waste, and may be used singularly or in a connected series to provide greater capacity. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Suction system canister, reusable

A cylindrical sealable container typically made of hard plastic materials used as a component of a suction system, or other system that utilizes suction, and which is designed for the collection of aspirated waste materials (e.g., blood, bodily fluids, rinsing fluids, laser plume evacuation gas) and/or body tissue intended for diagnostic/therapeutic purposes (e.g., histological analysis, autologous fat tissue transfer) from a site of operation. This device is typically used in conjunction with a dedicated disposable liner that confines and stores the contaminated waste, and may be used singularly or in a connected series to provide greater capacity. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
BTA	Pump, Portable, Aspiration (Manual Or Powered)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150134	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5427b20c-20c2-47bc-a1a0-0e5af26614b8
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2016