FDA UDI
In Commercial Distribution
🇺🇸 United States
BioShield
DI: 00724995183554
·
Model: 00711133
·
US Endoscopy
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- BioShield
- Primary DI
- 00724995183554
- Version / Model
- 00711133
- Catalog Number
- 00711133
- 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
- 6
- Public Version Date
- 2024-07-25
- Public Version Status
- Update
- Public Device Record Key
- d5011b8c-8dc8-403c-8a09-653fe87a71e7
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 |
| ODC | Endoscope channel accessory | Gastroenterology, Urology | 876.1500 | 2 |
| OCX | endoscopic irrigation/suction system | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62145 | Endoscope working-channel valve, single-use | A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10724995183551 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00724995183554 | GS1 | ||||
| Previous | 00816765011102 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry