FDA.reportPublic FDA data

haakaa

Primary DI
09420060206050
Brand
haakaa
Company
THINK GREEN LIMITED
Model
SGE070
Device description
Silicone Penguin Nasal Aspirator - Pro
Published
2026-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420060206050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420060206050094200602060509420060206050

GMDN Terms#

Term, Definition table
TermDefinition
Nasal aspirator, manualA portable, hand-held, manual suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It is available in a variety of forms including a compressible bulb with a tube that is inserted into the nares, or a syringe with a small bulb at its distal end that is applied to the nasal opening. It is designed for domestic use. This is a reusable device.

Regulatory Flags#

DUNS number
595005923
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09420060201055haakaaGBHK011-W2026-09-18
09420060201062haakaaGBHK011-R2026-09-18
09420060201079haakaaGBHK011-B2026-09-18
09420060201086haakaaGBHK011-V2026-09-18
09420060201093haakaaGBHK011-O2026-09-18
09420060201680haakaaMHK039-G-EX2026-09-18
09420060201697haakaaGBHK023-R2026-09-18
09420060201703haakaaGBHK1242026-09-18
09420060201710haakaaGBHK1252026-09-18
09420060202106haakaaAMZ006-L2026-09-18
09420060203073haakaaMHK100-B2026-09-18
09420060203080haakaaMHK144-B2026-09-18
09420060204094haakaaMHK1952026-09-18
09420060204100haakaaMHK1902026-09-18
09420060204117haakaaMHK2082026-09-18
09420060204124haakaaMHK2242026-09-20
09420060204131haakaaMHK2292026-09-20
09420060204148haakaaMHK2192026-09-20
09420060204155haakaaMHK2222026-09-20
09420060204162haakaaMHK2412026-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420060206036haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206043haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206067haakaaTHINK GREEN LIMITEDGCY2026-09-20
04710969717906Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mL, with Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717913Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717920Uresil Evolution Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159787Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159794Uresil Evolution PRE-VAC WOUND DRAINAGE BOTTLECanadian Hospital Specialties LimitedGCY2026-08-18
04719899159824Uresil Evolution Connecting Tube, with SpikeCanadian Hospital Specialties LimitedGCY2026-08-18
08718104890954Exsudex disposable canisterMeditop B.V.GCY2025-10-17
00848530106973Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530106980Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530106997Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530107000Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530107017Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530106966Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530107185Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-12
00848530106164Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-07-02
00848530106171Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-07-02
00848530106188Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-07-02
00848530095222Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106201Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106218Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106225Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106232Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106256Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106263Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106270Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530104467Suction KitSunset Healthcare Solutions, Inc.GCY2025-04-14
00848530103866Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-06