FDA.reportPublic FDA data

APA IP Shield™ DL

Primary DI
28885009190206
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 c
Published
2019-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
659177273
Device count
1
DM exempt
true
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
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841027103240Pedigo Products, Inc.PEDIGO PRODUCTS, INC.BRY2026-01-08
10885403533228BD PyxisCAREFUSION 303, INC.BRY2025-11-14
10885403533235BD PyxisCAREFUSION 303, INC.BRY2025-11-14
10885403533242PyxisCAREFUSION 303, INC.BRY2025-11-14
10885403532528Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-10-17
10885403521836Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-08-01
10885403521966Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-08-01
10885403521935Pyxis MedStationCAREFUSION 303, INC.BRY2025-07-23
10885403517822Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403517839Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403521225Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403521263Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403521270Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403521287Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403521294Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403521300Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522451Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522468Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522475Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522482Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522499Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522505Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522512Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522567Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522574Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522581Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522598Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522604Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522611Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05
10885403522628Pyxis Pro MedStationCAREFUSION 303, INC.BRY2025-06-05