Ambu 10-600177-1

GUDID 20818634025191

Ambu aScope 4 Cysto Reverse Deflection 5/Box

Bosma Enterprises

Flexible video cystoscope, single-use
Primary Device ID20818634025191
NIH Device Record Key6f645557-8335-4182-9c1d-3a19bdf3e88d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmbu
Version Model Number10-600177-1
Catalog Number10-600177-1
Company DUNS878070325
Company NameBosma Enterprises
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org
Phone800-362-5463
Emailkimm@bosma.org

Device Dimensions

Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter
Lumen/Inner Diameter2.2 Millimeter
Outer Diameter6 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100818634025197 [Unit of Use]
GS110818634025194 [Primary]
GS120818634025191 [Package]
Contains: 10818634025194
Package: Case [4 Units]
In Commercial Distribution

FDA Product Code

FAJCystoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-09
Device Publish Date2023-05-01

On-Brand Devices [Ambu]

20818634025191Ambu aScope 4 Cysto Reverse Deflection 5/Box
20818634025160Ambu aScope 4 Broncho Regular 5.0/2.2 5/Box
20818634025153AMBU aScope 4 Broncho Slim 3.8/1.2 5/Box
20818634025146Ambu aScope 4 Cysto 5/Box
20818634025139Ambu aScope 4 RhinoLaryngo Slim 5/Box
20818634025115Ambu aScope 4 Broncho Large 5.8/2.8 5/Box

Trademark Results [Ambu]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AMBU
AMBU
98192535 not registered Live/Pending
AMBU A/S
2023-09-22
AMBU
AMBU
90002202 not registered Live/Pending
AMBU
2020-06-15
AMBU
AMBU
79051291 3554442 Live/Registered
AMBU A/S
2008-02-15
AMBU
AMBU
74156351 1686178 Live/Registered
AMBU A/S
1991-04-12
AMBU
AMBU
73438330 1330624 Dead/Cancelled
Testa-Laboratorium A/S
1983-08-08
AMBU
AMBU
73023700 1040868 Dead/Expired
TESTA-LABORATORIUM A/S
1974-06-10
AMBU
AMBU
72127671 0740102 Dead/Cancelled
Testa Laboratorium A/S
1961-09-11
AMBU
AMBU
72055090 0705020 Dead/Cancelled
TESTA LABORATORIUM A/S
1958-07-10

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