FDA.reportPublic FDA data

BioGuard

Primary DI
10816765012991
Brand
BioGuard
Company
US Endoscopy
Model
00711783
Catalog number
00711783
Device description
The single use BioGuard air/water valve (3-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.
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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816765012991PackageGS150Not in Commercial Distribution
00816765012994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081676501299110816765012991
00816765012994008167650129948167650129940816765012994

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic biopsy valve, single-useA 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 a water input valve for simultaneous irrigation/biopsy. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10724995184015Endo-Boot00711621007116212020-04-01
10724995184022Endo-Boot00711622007116222020-04-01
00724995190637ProArmor00711623007116232020-07-16
00724995190644ProArmor00711624007116242020-07-16
00724995180355NA3905133905132020-04-02
00724995180362CO2MPACT7103007103002020-04-02
00724995180386NA7103047103042020-04-02
00724995180409NA7104247104242020-04-02
00724995180416NA7104257104252020-04-02
00724995180423NA7104267104262020-04-02
00724995180430NA7106027106022020-04-02
00724995180447NA7106037106032020-04-02
00724995180454NA7106047106042020-04-02
00724995180522Torrent00711579007115792020-04-01
00724995180768UltramatrixUSBOLUSBOL2020-04-02
00724995180775UltramatrixUSBORUSBOR2020-04-02
00724995180782iSnare00711084007110842020-03-19
00724995180843Articulator00711804007118042020-04-01
00724995182472Short Throw00711018007110182020-03-19
00724995182489Short Throw00711019007110192020-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956362666CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956486300CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956502703CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956539365CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956555563CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956567795CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956569317CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956578241CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956578593CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956582538CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956586628CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956588530CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956593787CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956594753CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956597617CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956598232CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956598928CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956599444CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956570733CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-30
10198956396906CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956552548CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956568419CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956568518CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956574564CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956590526CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956593824CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956594074CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956595903CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956388239CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956531697CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25