FDA.reportPublic FDA data

aScope BronchoSampler™Specimen Sampling System - Single Use

Primary DI
05707480137107
Brand
aScope BronchoSampler™Specimen Sampling System - Single Use
Company
Ambu A/S
Model
480200000
Catalog number
480200000
Device description
Ambu aScope BronchoSampler A Single-use, sterile and closed-loop system for bronchoscopic specimen sampling. Set included 2 container, 1 interface for sampling and 1 suction adapter. For integration with Ambu aScope 4 Broncho. Container volume 30ml, ETO sterilisation method. Minimum ordering is 5 pcs = 1 box
Published
2019-01-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBCBOTTLE, COLLECTION AND TRAP, BREATHING SYSTEM (UNCALIBRATED)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBCBottle, Collection And Trap, Breathing System (Uncalibrated)General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707480137114PackageGS15Not in Commercial Distribution
05707480137121PackageGS18Not in Commercial Distribution
05707480137107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480137114057074801371145707480137114
05707480137121057074801371215707480137121
05707480137107057074801371075707480137107

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical suction system, vacuumAn assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
305682023
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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05707480024537Ambu® Perfit Collar™0002642030002642032022-12-08
05707480024544Ambu® Perfit Collar™0002642040002642042022-12-08
05707480024551Ambu® Perfit Collar™0002642050002642052022-12-08
05707480024568Ambu® Perfit Collar™0002642060002642062022-12-08
05707480024575Ambu® Perfit Collar™0002645010002645012022-12-08
05707480024582Ambu® Perfit Collar™0002645020002645022022-12-08
05707480024599Ambu® Perfit Collar™0002645030002645032022-12-08
05707480024605Ambu® Perfit Collar™0002645040002645042022-12-08
05707480024612Ambu® Perfit Collar™0002645050002645052022-12-08
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05707480024636Ambu® Perfit ACE™0002810000002810002022-12-08
05707480024643Ambu® Military Perfit ACE™000281000MIL000281000MIL2022-12-08
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05707480037315Ambu® Immobilization Kit, with0002811520002811522022-12-08
05707480038619Ambu® Immobilization Kit, with0002811530002811532022-12-08

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