FDA.reportPublic FDA data

Respiratory Accessory

Primary DI
00852927004001
Brand
Respiratory Accessory
Company
Sunset Healthcare Solutions, Inc.
Model
RES6104L
Device description
RoEzIt Dermal Care - 1oz Tube
Published
2026-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NECBandage, Liquid, Skin Protectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NECBandage, Liquid, Skin ProtectantGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852927004008PackageGS118In Commercial Distribution
00852927004001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085292700400810852927004008
00852927004001008529270040018529270040010852927004001

GMDN Terms#

Term, Definition table
TermDefinition
Dry skin moisture barrier dressingA substance (e.g., cream, paste, ointment, gel, foam, or aerosol) intended to be applied to the skin/external mucosa (e.g., lips) to provide a protective moisture barrier to the external environment and/or to soften and sooth the skin. It is typically used for conditions such as dry, itchy, flaky, cracked, denuded, irritated or sun-damaged skin, cheilitis, and/or herpetic skin lesions. It may be intended for sensitive areas (e.g., areolar, perianal, lips, ears), dry skin and/or deep fissures (e.g., on the feet); it may include a disposable applicator. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530109875Ventilator accessoryVCMPV0012026-10-27
00848530110086Oxygen, Bacteria & HEPA FilterBF1412-32026-10-27
00848530093686Oxygen, Bacteria & HEPA FilterBF40002026-10-19
00848530109790Ventilator FilterVF015-12026-10-19
00848530109929Nebulizer and CompressorACTFISH2026-10-19
00848530109936Nebulizer and CompressorACTBEAR2026-10-19
00848530110031Ventilator FilterVF010-502026-10-19
00084853011017CPAP FilterCF1010F-502026-10-14
00848530109745CPAP FilterCF1015-42026-10-14
00848530109844CPAP FilterCF1015-6PL2026-10-14
00848530110024Oxygen KitADAPTO2SFTKIT2026-10-14
00848530110048Ventilator FilterVF010F-502026-10-14
00848530108885Breathing CircuitVC1002-R2026-10-12
00848530108892Breathing CircuitVC1002P-R2026-10-12
00848530109882CPAP FilterCF2111HA-10PL2026-09-30
00848530109899CPAP FilterCF2107HA-10PL2026-09-30
00848530109905Oxygen KitRESO2KITAZPL2026-09-30
00848530109912Nebulizer and CompressorACTNEB1002026-09-30
00848530109141Oxygen, Bacteria & HEPA FilterOF11003BR2026-06-30
00848530109165Oxygen, Bacteria & HEPA FilterOF11005BR2026-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850002835212Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835229Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835304Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835533Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835540Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835632Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835649Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007422Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007439Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007583Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007590Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007606Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007613Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
16958868743069BiokerzonRoosin Medical Co., Ltd.NEC2026-04-27
08904428721399OSSEOUS- Skin Closure TapeEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428721405OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745326OSSEOUS- Skin Closure TapeEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745333OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
10885632460296HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460302HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460319HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460326HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460290HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
20885632460309HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460313HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460320HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10197344042098MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
10197344042111MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
20197344042095MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
30197344042115MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26