AccessGUDID - DEVICE: Ambu® aScope™ 5 Cysto HD (05707480164462)

GUDID

Device Identifier (DI) Information

Brand Name: Ambu® aScope™ 5 Cysto HD
Version or Model: 602101000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 602101000
Company Name: Ambu A/S

Primary DI Number: 05707480164462
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: Flexible Cystoscope, Reverse Deflection

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61728	Flexible video cystoscope, single-use	A sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAJ	Cystoscope and accessories, flexible/rigid

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between 10 and 25 Degrees Celsius
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 6 Millimeter
Lumen/Inner Diameter: 2.2 Millimeter

Device Record Status

Public Device Record Key: 66547345-3e47-4dcb-bf23-194a547a9dd9
Public Version Date: November 14, 2024
Public Version Number: 1
DI Record Publish Date: November 06, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05707480164486	4	05707480164479		In Commercial Distribution
05707480164479	5	05707480164462		In Commercial Distribution

Secondary DI

[?]

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

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
CLOSE

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: +14107686464
Email: Purchase_orders@ambuUSA.com

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