DEVICE: CE Deliver (00867770000278)
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Device Identifier (DI) Information
CE Deliver
DLV
In Commercial Distribution
CAPSOVISION, INC.
DLV
In Commercial Distribution
CAPSOVISION, INC.
Capsule Endoscopy Deliver device for transendoscopic delivery to the stomach or duodenum
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| 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. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 62153 | Video capsule endoscopy system capsule introducer |
A non-sterile hand-held device intended to be introduced through a gastroscope to deliver a video capsule to the stomach/duodenum for the internal visualization and examination of the gastrointestinal (GI) tract. It is typically used in patients who are unable to swallow the video capsule or pass it beyond the pylorus in sufficient time. It is in the form of a shaft-like device with ring handles to control the release of the distally-mounted video capsule. This is a single-use device.
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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 [?] |
|---|---|
| K252480 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
ddef471c-e494-4e22-9373-f217fb07fba9
January 16, 2026
1
January 08, 2026
January 16, 2026
1
January 08, 2026
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 00867770000285 | 3 | 00867770000278 | In Commercial Distribution | Carton |
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
[?]
No Customer Contact currently defined