AccessGUDID - DEVICE: BioGuard (00816765013007)

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Device Identifier (DI) Information

Brand Name: BioGuard
Version or Model: 00711784
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00711784
Company Name: US Endoscopy

Primary DI Number: 00816765013007
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

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).

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Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
60738	Endoscopic insufflation tubing set, single-use	A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.	Active	false
60760	Endoscope channel support kit	A collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.	Active	false

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FDA Product Code

Product Code	Product Code Name
NWU	Endoscope introducer kit

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FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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Storage and Handling

Storage and Handling
Handling Environment Temperature: between 15 and 25 Degrees Celsius

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Clinically Relevant Size

Size Type Text
No Device Sizes

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Device Record Status

Public Device Record Key: e33ec973-91e8-4fc2-b16e-c57e2459a088
Public Version Date: July 25, 2024
Public Version Number: 10
DI Record Publish Date: February 22, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10816765013004	50	00816765013007	2020-03-31	Not in Commercial Distribution	Box

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Secondary DI

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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Unit of Use DI

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
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Production Identifier(s) in UDI

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

Phone: +1(800)548-4873
Email: xx@xx.xx

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