FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BioShield
DI: 10816765011093
·
Model: 00711131
·
US Endoscopy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- BioShield
- Primary DI
- 10816765011093
- Version / Model
- 00711131
- Catalog Number
- 00711131
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 7
- Public Version Date
- 2021-03-19
- Public Version Status
- Update
- Public Device Record Key
- 1a7c4d71-917d-40a1-b150-7910067dbe02
- Distribution End Date
- 2020-03-17
Device Description
The BioShield irrigating adaptor is used for intraprocedural gastrointestinal endoscopic irrigation when attached to a luer-lock or slip-tip syringe through the BioShield biopsy valve.
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 |
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 |
|---|---|---|---|---|---|---|
| Primary | 10816765011093 | GS1 | ||||
| Unit of Use | 00816765011096 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1 | Inch | |
| Needle Gauge | 15 | Gauge |