FDA.reportPublic FDA data

Earmates

Primary DI
00709078008566
Brand
Earmates
Company
WESTMED, INC.
Model
0440
Device description
Earmates, Charcoal (Pair)
Published
2020-06-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NVOSpacer, Direct Patient Interface

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVOSpacer, Direct Patient InterfaceAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078008563PackageGS150Not in Commercial Distribution
00709078008566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800856310709078008563
00709078008566007090780085667090780085660709078008566

GMDN Terms#

Term, Definition table
TermDefinition
Patient tube cushionA small patient-worn padding intended to function as a barrier between a patient tube/catheter (e.g., nasogastric tube, oxygen tube, surgical drain, laryngectomy or tracheostomy tube) and the skin to prevent irritation, maceration, and ulceration. It is typically made of a skin-friendly material (e.g., foam, silicone gel) designed to wrap/fit around the tube/catheter. This is a single-use device.

Regulatory Flags#

DUNS number
092673953
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00709078007781Composite Respiratory Kit07992019-10-18
00709078012693Septal-H Infant SizeCP-5500A2021-10-08
00709078012716Septal-H Pediatric SizeCP-5510A2021-10-08
00709078012990CapetteCP-42012021-06-25
00709078013003CapetteCP-42022021-06-25
00709078013010CapetteCP-42032021-06-25
00709078013027CapetteCP-44012021-06-25
00709078013034CapetteCP-44022021-06-25
00709078013041CapetteCP-44032021-06-25
00709078013058StrapetteCP-42042021-06-25
00709078013065StrapetteCP-42202021-06-25
00709078013072StrapetteCP-44042021-06-25
00709078013089StrapetteCP-44202021-06-25
00709078013096ChinstrapCP-51002021-06-25
00709078013102ChinstrapCP-52002021-06-25
00709078013119Septal-HCP-54002021-06-30
00709078013126Septal-HCP-54102021-06-30
00709078013133Septal-HCP-55002021-06-30
00709078013140Septal-HCP-55102021-06-30
00709078013157SavEarRT-61002021-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10709078008563Earmates WESTMED, INC.NVO2020-06-02
00709078002717Microspacer, BulkWESTMED, INC.NVO2017-02-20
10709078002714Microspacer, BulkWESTMED, INC.NVO2017-02-20