FDA.reportPublic FDA data

Ventilator Accessory

Primary DI
00848530110000
Brand
Ventilator Accessory
Company
Sunset Healthcare Solutions, Inc.
Model
VCMPV001-A
Device description
MPV Circuit Support Arm
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530110007PackageGS11In Commercial Distribution
00848530110000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853011000710848530110007
00848530110000008485301100008485301100000848530110000

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530110130Nasal CPAP MaskCM060-KITSLAB2026-11-03
00848530110147Oxygen KitCM060-KITLLAB2026-11-04
00848530110192CPAP MaskCM061SLAB2026-11-04
00848530110208CPAP MaskCM061MLAB2026-11-04
00848530110215CPAP MaskCM061LLAB2026-11-04
00848530110222CPAP MaskCM061XLLAB2026-11-04
00848530110284Oxygen KitAEAG002PKIT2026-11-03
00848530110291Oxygen KitAEAG002CKIT2026-11-03
00848530110307Breathing CircuitVEN004-CAP2026-11-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530110307Breathing CircuitSunset Healthcare Solutions, Inc.BZO2026-11-03
00848530109875Ventilator accessorySunset Healthcare Solutions, Inc.BZO2026-10-27
04055146499122Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499146Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499467Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499474Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499481Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499498Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499634Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055147001393Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055147001409Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146040935Breathing set, unheatedWILAmed GmbHBZO2026-10-19
04048675826088VentStar Coax GSL 180Drägerwerk AG & Co. KGaABZO2026-10-15
04048675826316Anesthesia Set Coax GSL 180Drägerwerk AG & Co. KGaABZO2026-10-15
05404013001507ClassicPlastiflex GroupBZO2026-09-21
05404013001521ClassicPlastiflex GroupBZO2026-09-21
00848530109813AerosolSunset Healthcare Solutions, Inc.BZO2026-09-09
14026704929204GIBECKTELEFLEX INCORPORATEDBZO2026-08-01
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