FDA UDI
In Commercial Distribution
🇺🇸 United States
PillCam
DI: 07290110361167
·
Model: FGS-0674
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PillCam
- Primary DI
- 07290110361167
- Version / Model
- FGS-0674
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-31
- Public Version
- 3
- Public Version Date
- 2022-11-01
- Public Version Status
- Update
- Public Device Record Key
- a2b6c732-94bc-415c-bcae-dad817cd544b
Device Description
PillCam™ WS, v9 USA
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290110361167 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170210 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 24 – 103 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 65 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity