AccessGUDID - DEVICE: BAG TEE ASSY-DIGITAL MDM (00816711020783)

GUDID

Device Identifier (DI) Information

Brand Name: BAG TEE ASSY-DIGITAL MDM
Version or Model: 30157400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30157400
Company Name: PARKER-HANNIFIN CORPORATION

Primary DI Number: 00816711020783
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004175550 *Terms of Use

Device Description: BAG TEE ASSY-DIGITAL MDM

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?
35425	Non-rebreathing valve, reusable	A non-sterile device that is a one-way valve used to direct the flow of breathing gases and prevent the patient rebreathing the exhaled gases. It is typically used in a breathing system or between an oxygen mask and its reservoir bag. The device may be of various designs and will typically include unidirectional valves made of, e.g., silicone, rubber, metal, mica, sheets or discs that open and close for each inspiration/expiration. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTC	Bag, Reservoir

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: 0ad21bbc-f8b7-4fe3-b9ef-59975437c5f8
Public Version Date: November 15, 2022
Public Version Number: 1
DI Record Publish Date: November 07, 2022