FDA.reportPublic FDA data

Micro Minimuffs

Primary DI
50628725095313
Brand
Micro Minimuffs
Company
CHS USA Inc.
Model
040342
Catalog number
040342
Device description
Minimuffs Neonatal Noise Attenuators
Published
2026-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EWEProtector, Hearing (Circumaural)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWEProtector, Hearing (Circumaural)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50628725095313PackageGS136In Commercial Distribution
00628725095318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872509531350628725095313
00628725095318006287250953186287250953180628725095318

GMDN Terms#

Term, Definition table
TermDefinition
Infant acoustic earmuffsA device consisting of two ear-covering cups (one for each ear) intended to provide noise insulation for neonates/infants in a special care unit. The cups are typically lined with sound attenuating material and held in place by hydrocolloid/hydro gel. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118995594
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
false
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
00628725095363Pleural Drain Dry Seal System H03100H031002026-04-17
00628725095370Pleural Drain Wet Seal System H03004H030042026-04-17
00628725095318Micro Minimuffs0403420403422026-01-07
00628725050041Epidural Anesthesia KitCPT10ATCPT10AT2025-11-24
00628725050058Epidural Anesthesia KitCPT4CPT42025-11-24
00628725050065Epidural Anesthesia KitCPT4EXCPT4EX2025-11-24
50628725050046Epidural Anesthesia KitCPT10ATCPT10AT2025-11-24
50628725050053Epidural Anesthesia KitCPT4CPT42025-11-24
50628725050060Epidural Anesthesia KitCPT4EXCPT4EX2025-11-24
00628725050027Nerve Block TrayCPT114CPT1142025-11-21
00628725050003Nerve Block TrayCPT11CPT112025-11-20
00628725050010Nerve Block TrayCPT11SPCPT11SP2025-11-20
00628725050034Nerve Block TrayCPT116CPT1162025-11-20
50628725050008Nerve Block TrayCPT11CPT112025-11-20
50628725050015Nerve Block TrayCPT11SPCPT11SP2025-11-20
50628725050039Nerve Block TrayCPT116CPT1162025-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628725095318Micro MinimuffsCHS USA Inc.EWE2026-01-07
00628725095295MiniMuffsCanadian Hospital Specialties LimitedEWE2025-04-11
50628725095290MiniMuffsCanadian Hospital Specialties LimitedEWE2025-04-11
10194484320734CondorGRAINGER INTERNATIONAL, INC.EWE2024-09-20
10194484320741CondorGRAINGER INTERNATIONAL, INC.EWE2024-09-20
20194484320731CondorGRAINGER INTERNATIONAL, INC.EWE2024-09-20
20194484320748CondorGRAINGER INTERNATIONAL, INC.EWE2024-09-20
00860008980700DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980717DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980724DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980731DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980748DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980755DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00860008980762DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00860008980779DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00860008980786DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00860008980793DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00033552000242Howard Leight by HoneywellSPERIAN HEARING PROTECTION, LLCEWE2020-09-22
00033552022053Howard Leight by HoneywellSPERIAN HEARING PROTECTION, LLCEWE2020-09-21
00033552015260 Howard Leight SPERIAN HEARING PROTECTION, LLCEWE2020-07-31
00033552015307 Howard Leight SPERIAN HEARING PROTECTION, LLCEWE2020-07-31
00033552019022Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
00033552022312Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
00033552025221Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
07312550119945Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
10033552015267 Howard Leight SPERIAN HEARING PROTECTION, LLCEWE2020-07-31
10033552015304 Howard Leight SPERIAN HEARING PROTECTION, LLCEWE2020-07-31
20033552019026Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
20033552022316Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
20033552025225Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31