AccessGUDID - DEVICE: aScope™ 4 Broncho Large 5.8/2.8 (05707480135530)

GUDID

Device Identifier (DI) Information

Brand Name: aScope™ 4 Broncho Large 5.8/2.8
Version or Model: 478001000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 478001000
Company Name: Ambu A/S

Primary DI Number: 05707480135530
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: Flexible Endoscope

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?
60963	Flexible video bronchoscope, single-use	An endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EOQ	Bronchoscope (flexible or 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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Length: 600 Millimeter
Outer Diameter: 5.8 Millimeter
Lumen/Inner Diameter: 2.8 Millimeter

Device Record Status

Public Device Record Key: ce34fbb0-2733-4ceb-af60-e530ba6e8c80
Public Version Date: March 05, 2025
Public Version Number: 7
DI Record Publish Date: July 04, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05707480135547	5	05707480135530		In Commercial Distribution	Box
05707480135554	4	05707480135547		In Commercial Distribution	Case

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(410)768-6464
Email: Purchase_orders@ambuUSA.com

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