AccessGUDID - DEVICE: Babi.Plus (04710810100802)

GUDID

Device Identifier (DI) Information

Brand Name: Babi.Plus
Version or Model: BC23-HD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port
Company Name: GALEMED CORPORATION

Primary DI Number: 04710810100802
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 656854379 *Terms of Use

Device Description: Distributed by Teleflex

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16803	Ventilator IMV supplemental circuit, single-use	A device designed to provide mandatory breathes to ventilator patients to supplement the spontaneous respiratory rate. It is typically constructed of plastics and consists of tubing and one-way valves. It will be used as an accessory on older ventilators without built-in intermittent mandatory ventilation (IMV) functions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZD	Ventilator, Non-Continuous (Respirator)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110383	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: 013bd926-8578-4a56-aa77-26aa281f20c0
Public Version Date: October 24, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2015