BioGuard
- Primary DI
- 00816765013007
- Brand
- BioGuard
- Company
- US Endoscopy
- Model
- 00711784
- Catalog number
- 00711784
- Device description
- The single use BioGuard air/water valve (4-piece) is used to control the air / water function of an endoscope during GI endoscopic procedures. The single use BioGuard suction valve is used to control the suction function of an endoscope during GI endoscopic procedures. The single use BioShield biopsy valve is used to cover the opening to the biopsy/suction channel of the gastrointestinal endoscope. The BioShield biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port thought the endoscopic procedure and provides access for irrigation. The single use Torrent irrigation scope connector is used in conjunction with the Torrent irrigation tubing to provide irrigation via irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump (or electrosurgical unit).
- Published
- 2017-02-22
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| NWU | Endoscope introducer kit |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NWU | Endoscope Introducer Kit | Gastroenterology, Urology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10816765013004 | Package | GS1 | 50 | Not in Commercial Distribution |
| 00816765013007 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10816765013004 | 10816765013004 | ||
| 00816765013007 | 00816765013007 | 816765013007 | 0816765013007 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Temperature | 15 Degrees Celsius | 25 Degrees Celsius |
Contacts#
| Phone | |
|---|---|
| +1(800)548-4873 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 627879687
- Device count
- 1
- Premarket exempt
- true
- Kit
- true
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10724995184015 | Endo-Boot | 00711621 | 00711621 | 2020-04-01 |
| 10724995184022 | Endo-Boot | 00711622 | 00711622 | 2020-04-01 |
| 00724995190637 | ProArmor | 00711623 | 00711623 | 2020-07-16 |
| 00724995190644 | ProArmor | 00711624 | 00711624 | 2020-07-16 |
| 00724995180355 | NA | 390513 | 390513 | 2020-04-02 |
| 00724995180362 | CO2MPACT | 710300 | 710300 | 2020-04-02 |
| 00724995180386 | NA | 710304 | 710304 | 2020-04-02 |
| 00724995180409 | NA | 710424 | 710424 | 2020-04-02 |
| 00724995180416 | NA | 710425 | 710425 | 2020-04-02 |
| 00724995180423 | NA | 710426 | 710426 | 2020-04-02 |
| 00724995180430 | NA | 710602 | 710602 | 2020-04-02 |
| 00724995180447 | NA | 710603 | 710603 | 2020-04-02 |
| 00724995180454 | NA | 710604 | 710604 | 2020-04-02 |
| 00724995180522 | Torrent | 00711579 | 00711579 | 2020-04-01 |
| 00724995180768 | Ultramatrix | USBOL | USBOL | 2020-04-02 |
| 00724995180775 | Ultramatrix | USBOR | USBOR | 2020-04-02 |
| 00724995180782 | iSnare | 00711084 | 00711084 | 2020-03-19 |
| 00724995180843 | Articulator | 00711804 | 00711804 | 2020-04-01 |
| 00724995182472 | Short Throw | 00711018 | 00711018 | 2020-03-19 |
| 00724995182489 | Short Throw | 00711019 | 00711019 | 2020-03-19 |
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