AccessGUDID - DEVICE: Coupling piece (07612367008327)

GUDID

Device Identifier (DI) Information

Brand Name: Coupling piece
Version or Model: 077.1018
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medela AG

Primary DI Number: 07612367008327
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 488293218 *Terms of Use

Device Description: Coupling Piece for tubing

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

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

GMDN Preferred Term Name	GMDN Definition
Suction system tubing, single-use	A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to connect a suction catheter to a collection bottle/canister, a collection canister/bottle to a regulator/suction pump, or to connect a series of collection bottles/canisters to increase the total capacity within a suction system. The device may be provided in rolls from which required lengths are cut, or in predetermined lengths with built-in connectors. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Suction system tubing, single-use

A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to connect a suction catheter to a collection bottle/canister, a collection canister/bottle to a regulator/suction pump, or to connect a series of collection bottles/canisters to increase the total capacity within a suction system. The device may be provided in rolls from which required lengths are cut, or in predetermined lengths with built-in connectors. This is a single-use 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 [?]
K130123	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: e42577b5-d669-49cd-8c2c-e95f9851db05
Public Version Date: February 07, 2019
Public Version Number: 4
DI Record Publish Date: October 03, 2016