FDA.reportPublic FDA data

Respiratory Accessory

Primary DI
00848530098513
Brand
Respiratory Accessory
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
RES052
Device description
POCKETPEAK Peak Flow Meters Universal-Range 50 to 720 LPM
Published
2024-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAXFlowmeter, Tube, Thorpe, Back-Pressure CompensatedAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530098513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530098513008485300985138485300985130848530098513

GMDN Terms#

Term, Definition table
TermDefinition
Medical gas flowmeter, Thorpe tubeA device intended to measure and regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It consists of an upright tube containing a float, which rises and falls in relation to gas flow, and a distal valve (compensated flowmeter) to control gas flow rate; some types include a pressure gauge/regulator. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530108854Breathing CircuitVC1001-R2026-05-12
00848530108861Breathing CircuitVC1001P-R2026-05-12
00848530108878Breathing CircuitVEN004-R2026-05-12
00848530080136Comfort Shoulder Bag for D CylindersCSBDCSBD2018-07-31
00848530089214Carry Bag for Portable Suction MachineSU100DC-BAGSU100DC-BAG2018-05-25
00848530100452Nebulizer AccessoriesNEB300-BAG2024-07-30
00848530086503Personal Device HolderCSBML6M72024-06-28
00848530086992Personal Device HolderCSBML6-Hardshell2024-06-28
00848530080143Wheelchair/Scooter Carrier for E CylindersCSBECSBE2018-07-31
00848530080150Comfort Shoulder Bag for B/M6 CylindersCSBM6CSBM62018-07-31
00848530080167Backpack for B/M6, C/M9 or Smaller CylindersCSBM6BPCSBM6BP2018-07-31
00848530080174Comfort Shoulder Bag for C/M9 CylindersCSBM9CSBM92018-07-31
00848530081942Flex O2 BagCSBM6FlexCSBM6Flex2018-07-31
00848530087173Backpack for D CylindersCSBDBPCSBDBP2018-07-31
00848530087784Cylinder Roller Bag & Backpack — Single D/E TankCSBD1RollerCSBD1Roller2018-07-31
00848530087968Bag for Compressor NebulizerNEB100-BAGNEB100-BAG2018-05-29
00848530108939Ventilator FilterVF005-22026-04-30
00848530108946Ventilator FilterVF003-22026-04-30
00848530108809Ventilator accessoryVEN0072026-04-27
00848530108847CPAP FilterCF1012-2PLC2026-04-27

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