FDA.report

aBox™ 2

Primary DI
05707480156207
Brand
aBox™ 2
Company
Ambu A/S
Model
505001000US1
Catalog number
505001000US1
Device description
Ambu aBox 2 US1
Published
2022-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FETEndoscopic video imaging system/component, gastroenterology-urology

Product Code Classifications

CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480156207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480156207057074801562075707480156207

GMDN Terms

TermDefinition
Endoscopic video image display monitorA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a flexible video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature040 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+14107686464Purchase_orders@ambuUSA.com

Regulatory Flags

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

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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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04953170437724Channel plugOLYMPUS MEDICAL SYSTEMS CORP.FET2023-04-22
04953170437731Injection tubeOLYMPUS MEDICAL SYSTEMS CORP.FET2023-04-22
04953170437748Water-resistant capOLYMPUS MEDICAL SYSTEMS CORP.FET2023-04-22
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04953170437946WASHING TUBEOLYMPUS MEDICAL SYSTEMS CORP.FET2023-04-22