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
00628725050218Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCPT10CPT102026-08-07
00628725050225Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCPT10SPCPT10SP2026-08-07
00628725050317Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCPT5SPGCPT5SPG2026-08-07
00628725050348Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCPT6SP45CPT6SP452026-08-07
00628725050386Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCPT7SPGCPT7SPG2026-08-07
00628725050324Epidural Anesthesia KitCPT4SPCPT4SP2026-07-17
00628725050416Epidural Anesthesia Kit Clint PharmaceuticalsCPT7CPT72026-07-21
00628725050287Nerve Block Tray Clint PharmaceuticalsCPT22Q45CPT22Q452026-07-20
00628725050294Nerve Block Tray Clint PharmaceuticalsCPT25Q35CPT25Q352026-07-20
00628725050300Epidural Anesthesia Kit Clint PharmaceuticalsCPT3CPT32026-07-20
00628725050331Epidural Anesthesia Kit Clint PharmaceuticalsCPT5CPT52026-07-20
00628725050362Epidural Anesthesia Kit Clint PharmaceuticalsCPT5SPCPT5SP2026-07-20
00628725050379Epidural Anesthesia Kit Clint PharmaceuticalsCPT6CPT62026-07-20
00628725050409Epidural Anesthesia Kit Clint PharmaceuticalsCPT6SPCPT6SP2026-07-20
00628725050423Epidural Anesthesia Kit Clint PharmaceuticalsCPT7SPCPT7SP2026-07-20
00628725050188Nerve Block TrayCPT110CPT1102026-07-17
00628725050195Nerve Block TrayCPT11CHCPT11CH2026-07-17
00628725050201Nerve Block TrayCPT11KCCPT11KC2026-07-17
00628725050232Epidural Anesthesia Kit Clint PharmaceuticalsCPT17SPGCPT17SPG2026-07-17
00628725050249Epidural Anesthesia Kit Clint PharmaceuticalsCPT18LCPT18L2026-07-17

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
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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
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20033552019026Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
20033552022316Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
20033552025225Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31