AccessGUDID - DEVICE: Little Sucker® and Cover (10812594010368)

GUDID

Device Identifier (DI) Information

Brand Name: Little Sucker® and Cover
Version or Model: Preemie
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N204
Company Name: Neotech Products LLC

Primary DI Number: 10812594010368
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 198013435 *Terms of Use

Device Description: The Little Sucker/ NeoSucker are indicated to be used as a tip for suction tubing to aspirate fluids from the mouth and nares. The Little Sucker Cover is indicated for use to protect the Little Sucker Device. The Suction Caddy is intended to hold and store a suction device.

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:	No
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?
10749	Airway suction catheter	A flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOL	Catheter And Tip, Suction

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 8c61f4b7-0e6d-44d1-91bc-6bdc9a0d187a
Public Version Date: September 21, 2023
Public Version Number: 7
DI Record Publish Date: February 20, 2017