AccessGUDID - DEVICE: aBox Duodeno (05707480145362)

GUDID

Device Identifier (DI) Information

Brand Name: aBox Duodeno
Version or Model: 485001000US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 485001000US
Company Name: Ambu A/S

Primary DI Number: 05707480145362
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: aBox Duodeno

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:	No
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?
18034	Endoscopic video image processing unit	An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDT	Duodenoscope and accessories, flexible/rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201098	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 80 and 109 KiloPascal
Handling Environment Atmospheric Pressure: between 80 and 109 KiloPascal
Storage Environment Temperature: between 10 and 25 Degrees Celsius
Handling Environment Temperature: between -5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9c2a4cfd-6c3d-4ff2-bd84-09380d7e8e84
Public Version Date: August 18, 2020
Public Version Number: 1
DI Record Publish Date: August 10, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +14107686464
Email: Purchase_orders@ambuUSA.com

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