N/A

GUDID 46923980105485

Neb.Easy AM-1 Mask, Child w/Tube

GaleMed Xiamen Co., Ltd.

Nebulizing system delivery set, single-use
Primary Device ID46923980105485
NIH Device Record Key175b96f4-ad4f-4568-a110-b161ed18cdd7
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberAD0051
Company DUNS527333326
Company NameGaleMed Xiamen Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106923980105487 [Primary]
GS146923980105485 [Package]
Contains: 06923980105487
Package: [50 Units]
In Commercial Distribution

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-30
Device Publish Date2026-01-22

On-Brand Devices [N/A]

06923980102028Berman Airway 9cm
06923980101939Guedel Airway 9cm, Yellow
06923980101922Guedel Airway 8cm, Green
06923980104435Disposable Anesthesia Circuit, Coaxial Circuit, Adult, 180cm
46923980108844Silicone J-Circuit, Adult
06923980104824Softip-1 Nasal Cannula, Adult
46923980114340PEEP Valve, 5-20cmH2O, 30F w/adapter
46923980104426Theta Circuit, 150cm
46923980104273Theta Circuit, 180cm
46923980115811Disposable Oxygen Tubing R2 Star Lumen Tubing, 200cm, 6M
46923980115194Coaxial Circuit, Adult, 1.5m
46923980115187Anesthesia Circuit, Adult, 1.8m
46923980115170Anesthesia Circuit, Adult, 1.2m
46923980115163Coaxial Circuit, Adult, 1.8m
46923980115156Anesthesia Circuit, Adult, 1.5m
46923980110502CPAP Face Mask Set w/Hose, S
46923980110496CPAP Face Mask Set w/Hose, M
46923980104747CPAP Face Mask Set w/Hose, L
46923980107281Connector, 15F, 10/7.6mm, K Resin
46923980103672Mouth Piece, 13M
46923980107748Connector, 15M, 5F, PP
46923980106420(10)Flex Trach Adaptor 15cm, 22M/15F-22F
46923980106413(10)Flex Trach Adapt 15cm,22M/15F-15M
46923980106406Flex Trach Adaptor 15cm, 22M/15F-22F
46923980105485Neb.Easy AM-1 Mask, Child w/Tube
46923980105461Neb.Easy AM-1 Mask, Adult w/Tube
46923980105430Neb.Easy Nebulizer w/Mouth Piece, Tube
46923980103689Neb.Easy AM-1 Mask, Infant w/Tube

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.