AccessGUDID - DEVICE: Heidelberg pH Capsule System (B989EC1150)

GUDID

Device Identifier (DI) Information

Brand Name: Heidelberg pH Capsule System
Version or Model: Heidelberg System Equipment Cart
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EC115
Company Name: Heidelberg Medical Inc

Primary DI Number: B989EC1150
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 023287700 *Terms of Use

Device Description: The cart (trolley) is a Non-Metallic 3 shelf mobile equipment cart, is used for transporting the Heidelberg pH Capsule systems devices.

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):	No
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?
36801	Utility trolley	A cart designed for transporting/supplying general-purpose goods, devices, medical equipment, or supplies within a hospital/institution department or ward. This trolley (cart) may have one or more open platforms and may have a handle(s) for pushing the trolley.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FFT	Electrode, Ph, Stomach

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: 2ca7c3b6-94fb-453d-b526-8416dd3e3f9c
Public Version Date: November 23, 2020
Public Version Number: 1
DI Record Publish Date: November 13, 2020