FDA.reportPublic FDA data

BioGuard

Primary DI
00724995180553
Brand
BioGuard
Company
US Endoscopy
Model
00711784
Catalog number
00711784
Device description
The single use BioGuard air water valve, 4-piece kit, includes BioShield biopsy valve and Torrent irrigation scope connector is used to control the air water function of an endoscope during GI endoscopic procedures and support infection prevention practices, providing an alternative to manual cleaning and reprocessing.
Published
2020-04-01
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 table
CodeName
PRTGastric irrigation and aspiration kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRTGastric Irrigation And Aspiration KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995180550PackageGS150Not in Commercial Distribution
00816765013007PreviousGS10
00724995180553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518055010724995180550
00816765013007008167650130078167650130070816765013007
00724995180553007249951805537249951805530724995180553

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@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 table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995180546BioGuardUS EndoscopyPRT2020-04-01
00724995183899NAUS EndoscopyPRT2020-04-01
00724995183905NAUS EndoscopyPRT2020-04-01
00724995183929NAUS EndoscopyPRT2020-04-01
00724995183936NAUS EndoscopyPRT2020-04-01
00724995183943NAUS EndoscopyPRT2020-04-01
10724995180543BioGuardUS EndoscopyPRT2020-04-01
10724995180550BioGuardUS EndoscopyPRT2020-04-01
10724995183896NAUS EndoscopyPRT2020-04-01
10724995183902NAUS EndoscopyPRT2020-04-01
10724995183926NAUS EndoscopyPRT2020-04-01
10724995183933NAUS EndoscopyPRT2020-04-01
10724995183940NAUS EndoscopyPRT2020-04-01