AccessGUDID - DEVICE: MediPines Single Patient Use Breathing Circuit (00860001261516)

GUDID

Device Identifier (DI) Information

Brand Name: MediPines Single Patient Use Breathing Circuit
Version or Model: AGM316
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AGM316-10, AGM316-50, AGM316-100
Company Name: MEDIPINES CORPORATION

Primary DI Number: 00860001261516
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 058309398 *Terms of Use

Device Description: Breathing Circuit Kit, Single Patient Use, 10

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?
44545	Breathing mouthpiece, single-use	A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
BZL	Computer, Oxygen-Uptake

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180902	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
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between -25 and 70 Degrees Celsius
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8532f342-0cca-4c3f-8cb9-f2766f31698c
Public Version Date: July 06, 2023
Public Version Number: 5
DI Record Publish Date: March 25, 2019