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

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

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00816486021688Genesis™ 16 CHG EXTPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021763Genesis™ 13 144 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021770Genesis™ 13 45 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021787Genesis™ 13 60 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021794Genesis™ 13 84 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021800Genesis™ 13 15 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021817Genesis™ 13 28 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021824Genesis™ 13 36 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021831Genesis™ 13 8 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021848Genesis™ 13 15 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021855Genesis™ 13 28 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021862Genesis™ 13 36 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
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00816486021909Genesis™ 13 84 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021916Genesis™ 13 144 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021923Genesis™ 16 144 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021930Genesis™ 16 45 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021947Genesis™ 16 60 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021954Genesis™ 16 84 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021961Genesis™ 16 15 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021978Genesis™ 16 28 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021985Genesis™ 16 36 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021992Genesis™ 16 8 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21