FDA.reportPublic FDA data

UESCOPE Single-Use Laryngoscope Blade, Size MA1

Primary DI
16970283489230
Brand
UESCOPE Single-Use Laryngoscope Blade, Size MA1
Company
Zhejiang UE Medical Corp
Model
UED-MA1
Published
2024-12-17
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

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
16970283489230PackageGS120In Commercial Distribution
26970283489237PackageGS110In Commercial Distribution
06970283489233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697028348923016970283489230
2697028348923726970283489237
06970283489233069702834892336970283489233

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

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
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
06970283481695UESCOPE Disposable Laryngoscope Blade, Size 4UED-42022-09-09

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