AccessGUDID - DEVICE: CapsoCloud (00867770000223)

GUDID

Device Identifier (DI) Information

Brand Name: CapsoCloud
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CLD
Company Name: CAPSOVISION, INC.

Primary DI Number: 00867770000223
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789635740 *Terms of Use

Device Description: Web-based software for managing the CapsoCam Plus procedures used by health care providers, readers, download centers, and upload centers, also providing online video reviewing and reporting functionalities.

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?
37358	Video capsule endoscopy system application software	A software program intended to be used with a video capsule endoscopy system control unit or an off-the-shelf computer to receive, display, process and/or manage (e.g., communicate, store) photographic image data from an ingested video capsule (not included), and/or to adjust capsule settings [e.g., position in the gastrointestinal (GI) tract]. It is intended for use by a healthcare professional in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192662	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: 61a99d91-19db-4e90-8b73-e7e067a8f9ac
Public Version Date: December 10, 2020
Public Version Number: 3
DI Record Publish Date: March 02, 2020