FDA.reportPublic FDA data

DREAMIES T-M

Primary DI
00860008980748
Brand
DREAMIES T-M
Company
NEATCAP MEDICAL LLC
Model
Size XL
Catalog number
NEAT005-05
Device description
The NEATCAP® DREAMIES® T-M device is a single use medical device designed to provide hearing protection for infants during air or ground hospital transport, or magnetic resonance imaging (MRI). The Size XL device is designed for use on infants with a head circumference measuring 41-48cm. NEATCAP® DREAMIES® T-M devices are packaged non-sterile.
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

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
00860008980748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008980748008600089807488600089807480860008980748

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.

Contacts#

Phone, Email table
PhoneEmail
888-403-6328info@neatcapmedical.com

Regulatory Flags#

DUNS number
075105568
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008980700DREAMIES T-MSize XSNEAT005-012022-12-08
00860008980717DREAMIES T-MSize SNEAT005-022022-12-08
00860008980724DREAMIES T-MSize MNEAT005-032022-12-08
00860008980731DREAMIES T-MSize LGNEAT005-042022-12-08
00860008980755DREAMIESSize XSNEAT004-012022-12-08
00860008980762DREAMIESSize SNEAT004-022022-12-08
00860008980779DREAMIESSize MNEAT004-032022-12-08
00860008980786DREAMIESSize LGNEAT004-042022-12-08
00860008980793DREAMIESSize XLNEAT004-052022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628725095318Micro MinimuffsCHS USA Inc.EWE2026-01-07
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
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