FDA.reportPublic FDA data

APA IP Shield™ DL

Primary DI
18885009190209
Brand
APA IP Shield™ DL
Company
VENNER MEDICAL (SINGAPORE) PTE. LTD.
Model
701010
Catalog number
701010
Device description
A non-sterile device typically designed as a moulded plastic sleeve intended to be placed over the reusable laryngoscope device during intubation to create a barrier in order to reduce the cleaning time and turnaround time of the laryngoscope blade for reuse
Published
2019-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
BRYCabinet, Table And Tray, Anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRYCabinet, Table And Tray, AnesthesiaAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28885009190206PackageGS1200In Commercial Distribution
18885009190209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2888500919020628885009190206
1888500919020918885009190209

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade coverA non-sterile device typically designed as a moulded plastic sleeve intended to be placed over the reusable blade and upper portion of the handle of a laryngoscope (i.e., rigid intubation type) during intubation to create a barrier in order to reduce the cleaning time and turnaround time of the laryngoscope blade for reuse. It is typically held in place with a rubber band or clip. This is a single-use device.

Regulatory Flags#

DUNS number
659177273
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08885009190752Venner™ PneuX P.Y.™ ETT MRI9011609011602016-09-24
08885009190769Venner™ PneuX P.Y.™ ETT MRI9011709011702016-09-24
08885009190776Venner™ PneuX P.Y.™ ETT MRI9011809011802016-09-24
08885009190783Venner™ PneuX P.Y.™ ETT MRI9011909011902016-09-24
08885009190820Venner™ PneuX P.Y.™ TT MRI9021709021702016-09-24
08885009190837Venner™ PneuX P.Y.™ TT MRI9021809021802016-09-24
08885009190844Venner™ PneuX P.Y.™ TT MRI9021909021902016-09-24
08885009190707Venner™ Tracheal Seal Monitor9032009032002016-09-24
08885009190714Venner™ PneuX P.Y.™ ETT 9010609010602016-09-24
08885009190721Venner™ PneuX P.Y.™ ETT9010709010702016-09-24
08885009190738Venner™ PneuX P.Y.™ ETT9010809010802016-09-24
08885009190745Venner™ PneuX P.Y.™ ETT9010909010902016-09-24
08885009190790Venner™ PneuX P.Y.™ TT9020709020702016-09-24
08885009190806Venner™ PneuX P.Y.™ TT9020809020802016-09-24
08885009190813Venner™ PneuX P.Y.™ TT9020909020902016-09-24
08885009190196APA™ Stylet 7010097010092019-02-25
08885009190851Venner™ Tracheal Seal Monitor Extension Tube9030019030012016-09-24
28885009190855Venner™ Tracheal Seal Monitor Extension Tube9030019030012016-09-24
08885009190325APA™ O2 MAC 3 Blade7003307003302019-08-22
08885009190332APA™ O2 MAC 4 Blade7003407003402019-08-22

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