FDA.report

aScope BronchoSampler™ 60 SC

Primary DI
05707480156580
Brand
aScope BronchoSampler™ 60 SC
Company
Ambu A/S
Model
480500000US
Catalog number
480500000US
Device description
aScope BronchoSampler 60 SC / US
Published
2022-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMHCONTAINER, SPECIMEN, STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480156580PackageGS110In Commercial Distribution
05707480156597PackageGS18In Commercial Distribution
05707480156573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480156580057074801565805707480156580
05707480156597057074801565975707480156597
05707480156573057074801565735707480156573

GMDN Terms

TermDefinition
Bronchoscopic specimen collection containerA 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.

Device Sizes

TypeValueUnit
Total Volume60Milliliter

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags

DUNS number
305682023
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05707480006427Perfit Collar™0002642040002642042022-12-08
05707480006434Perfit Collar™0002642050002642052022-12-08
05707480006441Perfit Collar™0002642060002642062022-12-08
05707480006458Perfit Collar™0002645010002645012022-12-08
05707480006465Perfit Collar™0002645020002645022022-12-08
05707480006472Perfit Collar™0002645030002645032022-12-08
05707480006489Perfit Collar™0002645040002645042022-12-08
05707480006496Perfit Collar™0002645050002645052022-12-08
05707480018420Perfit ACE™0002810000002810002022-12-08
05707480018437Military Perfit ACE™000281000MIL000281000MIL2022-12-08
05707480006526Mini Perfit ACE™0002811060002811062022-12-08
05707480025459AuraOnce321100000U321100000U2022-12-08
05707480025473AuraOnce321200000U321200000U2022-12-08
05707480025497AuraOnce321300000U321300000U2022-12-08
05707480025503AuraOnce321400000U321400000U2022-12-08
05707480025435AuraOnce321500000U321500000U2022-12-08
05707480025527AuraOnce321600000U321600000U2022-12-08

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