DEVICE: RAPID (07290101366478)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
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 [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
15608219-bb2b-4857-9b50-778e33eb849e
August 08, 2023
9
September 24, 2016
August 08, 2023
9
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(508)261-8000
covidien.udi@covidien.com
covidien.udi@covidien.com