FDA.reportPublic FDA data

PillowCase

Primary DI
00850042446195
Brand
PillowCase
Company
HATCHMED CORPORATION
Model
HMNF-4003
Catalog number
HMNF-4101
Device description
Responder 5 DIN module for PillowCase
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILQSystem, Communication, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850042446195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042446195008500424461958500424461950850042446195

GMDN Terms#

Term, Definition table
TermDefinition
Pillow speakerA loudspeaker intended to be used by a patient when lying in bed or resting in a chair by putting it close to their ear or between a pillow and their ear. It is typically designed as a small pillow-like device that contains a loudspeaker and that has a cable and a connector for connection to a radio, television, or other sound-emitting device with a Jack plug sound outlet. The sound level is regulated by the user with an adjustable control. It is typically used to create a relaxing atmosphere with music, for entertainment (e.g., to listen to the radio), and to aid sleep and relieve tinnitus.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
884-428-2463support@hatchmed.com

Regulatory Flags#

DUNS number
118680908
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850042446546HighLightHMNE-4500HMNE-45002026-05-15
00850042446515BlackJackMP2MP22026-01-01
00850042446522BlackJackMP6MP62026-01-01
00850042446539BlackJackMP12MP122026-01-01
00850042446485PadLockHMNF-2305HMNF-23052025-06-13
00850042446478PadLockHMNF-23042025-06-02
00850042446492HallMonitorHMNF-3912HMNF-39122025-06-02
00850042446508HallMonitorHMNF-3921HMNF-39212025-06-02
00850042446461PadLockHMNF-2302HMNF-23022025-05-15
00850042446201PillowCaseHMNF-70042023-02-01
00850042446010PillowCaseHMNF70022022-09-01
00850042446454BlackJackMR4MR42025-04-01
00850042446416HighLIghtHMNE-3277HMNE-32772025-01-31
00850042446423BlueJackHMNE-4000HMNE-40002025-01-31
00850042446430BlueJackHMNE-4100HMNE-41002025-01-31
00850042446447PadLockHMNF-2301HMNF-23012025-01-31
00850042446409PillowCaseHMNF-7004AHMNF-7004A2024-08-16
00850042446386BlackJackFR7FR72024-06-14
00850042446393BlackJackMR72024-06-14
00850042446379BlackJackFR3FR32024-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812324018315Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018322Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018339Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018346Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018353Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018360Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018377Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018384Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018391Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018407Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018414Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018421Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018438Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018445Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018452Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018469Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018476Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018483Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018490Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018506Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018513Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00887761943131Voalte Nurse CallHILL-ROM, INC.ILQ2026-09-28
00840828197014RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-08-18
00840828196895PAD-CORDED,UNDER SEAT,10"X15",92" CORDCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-23
00840828196901PAD WIRELESS, UNDER SEAT, 10"X15"CURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-23
00840828196710P4600 90°,S4600,1 FT,R6,PS BREAKAWAYCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
008408281967274600,R6,BASIC,2 LT,DVCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
008408281967344600,R6,ENH,2 LT,DVCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
00840828196741RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
00840828196765RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08