aScope BronchoSampler™ 60 SC

Basic Information

• Brand Name: aScope BronchoSampler™ 60 SC
• Primary DI: 05707480156573
• Version / Model: 480500000US
• Catalog Number: 480500000US
• Company Name: Ambu A/S
• Labeler DUNS: 305682023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-19
• Public Version: 3
• Public Version Date: 2026-01-30
• Public Version Status: Update
• Public Device Record Key: c84d4289-6fac-4226-bc8f-29a209da2ed6

Device Description

Sample Container

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMH	CONTAINER, SPECIMEN, STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66115	Bronchoscopic specimen collection container	A noninvasive receptacle containing no additives intended to be used for the collection/sampling, and preservation and/or transport, of a bronchial fluid specimen during a bronchoscopic therapeutic procedure [e.g., bronchoalveolar lavage (BAL), bronchial wash], typically for subsequent microbiological analysis. It is designed to be attached to a bronchoscope connected to a suction source. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05707480156580	GS1		10	In Commercial Distribution
Primary	05707480156573	GS1
Package	05707480156597	GS1		8	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	60	Milliliter

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius