FDA.reportPublic FDA data

PreciseRx™ Pediatric Flowmeter

Primary DI
00850018761291
Brand
PreciseRx™ Pediatric Flowmeter
Company
Ventec Life Systems, Inc.
Model
IRCPF16
Catalog number
IRCPF16
Published
2023-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CAWGenerator, Oxygen, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAWGenerator, Oxygen, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914488000MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITSInvacare Corp.1992-09-15CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018761291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018761291008500187612918500187612910850018761291

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit95 Degrees Fahrenheit
Storage Environment Temperature-20 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078758082
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018761048VOCSN Patient Breathing PackageAdult, Active, Oxygen, BluePRT-00794-00X2020-10-07
00850018761062VOCSN Patient Breathing PackageAdult, Active, Heated, Oxygen, BluePRT-00798-00X2020-10-07
00850018761116VOCSNV+C, JapanesePRT-01098-1XX2021-02-23
00855573007013VOCSN External Bacterial FilterPRT-00790-001PRT-00790-0032017-11-11
00855573007037VOCSN Patient Breathing PackageAdult, Active, Oxygen, BluePRT-00794-0012017-11-11
00855573007044VOCSN Patient Breathing PackageAdult, Passive, Oxygen, BluePRT-00793-0012017-11-11
00855573007075VOCSN Patient Breathing PackageAdult, Passive, BluePRT-00792-0012019-01-30
00855573007082VOCSN Patient Breathing PackageAdult, Active, Heated, BluePRT-00795-0012019-01-30
00855573007099VOCSN Patient Breathing Package Adult, Passive, Heated, BluePRT-00796-0012019-01-30
00855573007105VOCSN Nurse Call CableNormally ClosedPRT-00820-0012017-11-11
00855573007112VOCSN Nurse Call CableNormally OpenPRT-00821-0012017-11-11
00855573007129VOCSN Travel Suction CanisterPRT-00824-000PRT-00824-0012017-11-11
00855573007181VOCSN Patient Breathing PackagePediatric, Valveless, BluePRT-00927-0012019-01-30
00855573007228VOCSN Patient Breathing PackageAdult, Valveless, BluePRT-00926-0012019-01-30
00855573007235VOCSN Patient Breathing PackageAdult, Valveless, Heated, BluePRT-00928-0012019-01-30
00855573007341VOCSN Patient Breathing PackagePediatric, Valveless, Heated, BluePRT-00929-0012019-01-30
00855573007549VOCSN Patient Breathing PackagePediatric, Active, BluePRT-00799-0012018-07-10
00855573007563VOCSN Patient Breathing PackagePediatric, Active, Heated, BluePRT-00803-0012018-07-11
00855573007587VOCSN Patient Breathing PackagePediatric, Active, Oxygen, BluePRT-00802-0012018-07-11
00855573007600VOCSN Patient Breathing PackagePediatric, Active, Heated, Oxygen, BluePRT-00806-0012018-07-11

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00860007698262MOSTPacific Consolidated Industries LLCCAW2026-05-06
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