FDA UDI
In Commercial Distribution
🇺🇸 United States
BioShield
DI: 00724995183592
·
Model: 00711137
·
US Endoscopy
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BioShield
- Primary DI
- 00724995183592
- Version / Model
- 00711137
- Catalog Number
- 00711137
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-19
- Public Version
- 5
- Public Version Date
- 2023-10-27
- Public Version Status
- Update
- Public Device Record Key
- 8a86ab16-3ce0-44a3-bd56-dda8d6e17adb
Device Description
The BioShield irrigator is used with gastrointestinal endoscopes and allows for remote irrigation via an attached irrigation line.
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
- Yes
- 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 |
|---|---|---|---|---|
| ODD | Endoscopic retrograde cholangiopancreatography (ERCP) cannula | Gastroenterology, Urology | 876.1500 | 2 |
| OCX | endoscopic irrigation/suction system | Gastroenterology, Urology | 876.1500 | 2 |
| ODC | Endoscope channel accessory | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62145 | Endoscopic biopsy valve, single-use | A device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10724995183599 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00724995183592 | GS1 | ||||
| Previous | 00816765011140 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry