FDA.report

aScope™ 5 Broncho HD 5.0/2.2 Sampler Set

Primary DI
05707480156535
Brand
aScope™ 5 Broncho HD 5.0/2.2 Sampler Set
Company
Ambu A/S
Model
621002000US
Catalog number
621002000US
Device description
aScope 5 Broncho HD 5.0/2.2 Sampler Set
Published
2023-03-11
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
EOQBronchoscope (flexible or rigid)

Product Code Classifications

CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480156528PackageGS15In Commercial Distribution
05707480156535PackageGS14In Commercial Distribution
05707480156511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480156528057074801565285707480156528
05707480156535057074801565355707480156535
05707480156511057074801565115707480156511

GMDN Terms

TermDefinition
Flexible video bronchoscope, single-useAn 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.

Device Sizes

TypeValueUnit
Length600Millimeter
Lumen/Inner Diameter2.2Millimeter
Outer Diameter5Millimeter

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
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05707480006397Perfit Collar™0002642010002642012022-12-08
05707480006403Perfit Collar™0002642020002642022022-12-08
05707480006410Perfit Collar™0002642030002642032022-12-08
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810116024049Dornier MedTech DORNIER MEDTECH AMERICA, INC.EOQ2026-03-24
06937048207884UE DisplayZhejiang UE Medical CorpEOQ2026-02-26
16937048207898UE BRONCHO Single-Use BronchoscopesZhejiang UE Medical CorpEOQ2026-02-26
16937048207904UE BRONCHO Single-Use BronchoscopesZhejiang UE Medical CorpEOQ2026-02-26
16937048207911UE BRONCHO Single-Use BronchoscopesZhejiang UE Medical CorpEOQ2026-02-26
14547410520580FUJIFILMFUJIFILM CORPORATIONEOQ2026-01-23
00860009430204Recon Steerable SheathSERPEX MEDICAL INC.EOQ2025-12-08
06975202770287EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770294EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770300EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770317EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770478EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770485EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770492EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770508EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770515EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770522EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
00886874124871Ion Tomosynthesis BoardINTUITIVE SURGICAL, INC.EOQ2025-11-11
10810068811275Extended Patient Introducer MountAuris Health, Inc.EOQ2025-09-04
06975339626624Mounting HolderMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
06975339626631Mounting HolderMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626642ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
06975339626655ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626666ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626673ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626680ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626697ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
06975339626709HDMI cableMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
06975339626716Power adapterMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
06975339626723Power adapterMacroLux Medical Technology Co., Ltd.EOQ2025-08-23