FDA.reportPublic FDA data

Willnice

Primary DI
16977434730012
Brand
Willnice
Company
Shenzhen Sany Pioneer Technology Co.,Ltd
Model
WLN02-01
Device description
Willnice is a non-powered, single-person, portable suction device.
Published
2024-05-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16977434730012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697743473001216977434730012

GMDN Terms#

Term, Definition table
TermDefinition
Emergency airway clearance suction plungerA noninvasive, manual device designed for the emergency removal of an airway-obstructing object or material in the oropharynx, trachea, or bronchi to prevent patient asphyxiation. It is in the form of a compression tank (plunger) connected to a face-fitting mask that is applied to the mouth area; the plunger is manually compressed and expanded to provide a negative pressure within the airway to suck out the obstructing material. This is a single-use device.

Regulatory Flags#

DUNS number
415478661
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
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
00850088881028ItAllJoymask 202026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08682952418014PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-13
10198956013704CARDINAL HEALTHCardinal Health 200, LLCGCX2025-05-09
08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08