FDA UDI
In Commercial Distribution
🇺🇸 United States
CE Deliver
DI: 00867770000278
·
Model: DLV
·
CAPSOVISION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CE Deliver
- Primary DI
- 00867770000278
- Version / Model
- DLV
- Company Name
- CAPSOVISION, INC.
- Labeler DUNS
- 789635740
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-08
- Public Version
- 1
- Public Version Date
- 2026-01-16
- Public Version Status
- New
- Public Device Record Key
- ddef471c-e494-4e22-9373-f217fb07fba9
Device Description
Capsule Endoscopy Deliver device for transendoscopic delivery to the stomach or duodenum
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | Gastroenterology, Urology | 876.1300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00867770000285 | GS1 | Carton | 3 | In Commercial Distribution | |
| Primary | 00867770000278 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252480 | 000 |