FDA.reportPublic FDA data

RESUSCITATION ACCESSORY

Primary DI
00848530105013
Brand
RESUSCITATION ACCESSORY
Company
Sunset Healthcare Solutions, Inc.
Model
RES8201LNS
Device description
Sunset Disposable Pressure Manometer, L-Shape - 25PCS
Published
2025-08-20
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530105013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530105013008485301050138485301050130848530105013

GMDN Terms#

Term, Definition table
TermDefinition
Airway pressure monitor, non-poweredA mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.

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
true
Expiration date on label
true
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
00848530109141Oxygen, Bacteria & HEPA FilterOF11003BR2026-06-30
00848530109165Oxygen, Bacteria & HEPA FilterOF11005BR2026-06-30
00848530109295Oxygen kitAATH006O2KIT2026-06-11
00848530109462Nasal CPAP MaskCM060-KITLNV2026-07-15
00848530109479Nasal CPAP MaskCM060L-NV2026-07-15
00848530109486Nasal CPAP MaskCM060XL-NV2026-07-15
00848530109523Oxygen KitAHOW001O2KIT2026-08-20
00848530109592Ventilator FilterVF010-12026-08-20
00848530109608Ventilator FilterVF010F-12026-08-20
00848530109639Nasal CPAP MaskCM060SNH2026-08-24
00848530109646Nasal CPAP MaskCM060MNH2026-08-24
00848530109653CPAP MaskCM061SNH2026-08-24
00848530109660CPAP MaskCM061MNH2026-08-24
00848530109691CPAP HeadgearHG060B2026-09-09
00848530109721OXYGEN CONNECTOR/ADAPTERRES019-1PL2026-09-09
00848530109738CPAP FilterCF1015NS2026-08-31
00848530109783Oxygen AccessoryPOCBAG-P22026-09-09
00848530109813AerosolTUB100-1FT15MM2026-09-09
00848530109820Ventilation AccessoryVEN008NS2026-09-09
00848530109837Ventilation AccessoryRES096MPNS2026-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902224931LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-09-18
06920687314020INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314037INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314044INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314051INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314068INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314075INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314082INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314099INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314105INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314112INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314129INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314136INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314143INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314150INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314167INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314174INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314181INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314198INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314204INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314211INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314228INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314235INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314242INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314259INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314303INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314310INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314327INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314334INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06946430427632CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2026-08-08