FDA.reportPublic FDA data

UESCOPE Single-Use Laryngoscope Blade, Size A4

Primary DI
16970283489193
Brand
UESCOPE Single-Use Laryngoscope Blade, Size A4
Company
Zhejiang UE Medical Corp
Model
UED-A4
Published
2022-09-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970283489193PackageGS120In Commercial Distribution
26970283489190PackageGS110In Commercial Distribution
06970283489196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697028348919316970283489193
2697028348919026970283489190
06970283489196069702834891966970283489196

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade, single-useThe segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8657687788798export@ueworld.com

Regulatory Flags#

DUNS number
542992969
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937048207891UE BRONCHO Single-Use BronchoscopesEBS-380C2026-02-26
06937048207907UE BRONCHO Single-Use BronchoscopesEBS-500C2026-02-26
06937048207914UE BRONCHO Single-Use BronchoscopesEBS-600C2026-02-26
06937048207884UE DisplayUE-M10S2026-02-26
16937048207898UE BRONCHO Single-Use BronchoscopesEBS-380C2026-02-26
16937048207904UE BRONCHO Single-Use BronchoscopesEBS-500C2026-02-26
16937048207911UE BRONCHO Single-Use BronchoscopesEBS-600C2026-02-26
06970283489219UESCOPE Single-Use Laryngoscope Blade, Size A1UED-A12024-12-17
06970283489226UESCOPE Single-Use Laryngoscope Blade, Size A0UED-A02024-12-17
06970283489233UESCOPE Single-Use Laryngoscope Blade, Size MA1UED-MA12024-12-17
16970283489216UESCOPE Single-Use Laryngoscope Blade, Size A1UED-A12024-12-17
16970283489223UESCOPE Single-Use Laryngoscope Blade, Size A0UED-A02024-12-17
16970283489230UESCOPE Single-Use Laryngoscope Blade, Size MA1UED-MA12024-12-17
06970283489394UE Intubation StyletP32024-12-17
06970283489400UESCOPE Single-Use Laryngoscope Blade, Size J3J32024-12-17
06970283489424UE Intubation StyletP22024-12-17
06970283489417UE Intubation StyletP12024-12-16
06970283483941UE DisplayVL4602022-09-05
06970283481633UESCOPE Disposable Laryngoscope Blade, Size 2UED-22022-09-09
06970283481664UESCOPE Disposable Laryngoscope Blade, Size 3UED-32022-09-09

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08436031033922AirtraqPRODOL MEDITEC, SACCW2023-08-01
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08436031035117AirtraqPRODOL MEDITEC, SACCW2023-08-01
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08436031035902AirtraqPRODOL MEDITEC, SACCW2023-08-01
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