FDA.reportPublic FDA data

Micro Minimuffs

Primary DI
00628725095318
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
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.

Regulatory Flags#

DUNS number
118995594
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
00628725095363Pleural Drain Dry Seal System H03100H031002026-04-17
00628725095370Pleural Drain Wet Seal System H03004H030042026-04-17
50628725095313Micro 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
50628725095313Micro 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