FDA.reportPublic FDA data

Invacare® PreciseRx™ Pediatric Flowmeter

Primary DI
00841447100157
Brand
Invacare® PreciseRx™ Pediatric Flowmeter
Company
INVACARE CORPORATION
Model
IRCPF16
Catalog number
IRCPF16
Published
2015-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00841447100157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841447100157008414471001578414471001570841447100157

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 Temperature-29 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Temperature-29 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-329-6000orders@invacare.com

Regulatory Flags#

DUNS number
076916246
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05600494139948Invacare Birdie Evo XPlus Full Body LiftBRDXPLUSBRDXPLUS2026-06-03
00841447116431Invacare® Alternating Air Mattress & PumpMA101BLMA101BL2026-05-01
00841447116448Invacare® Alternating Air Mattress & PumpMA101BKMA101BK2026-05-01
00841447116455Invacare® Alternating Air Mattress & Pump with Static ModeMA102BLMA102BL2026-05-01
00841447116462Invacare® Alternating Air Mattress & Pump with Static ModeMA102BKMA102BK2026-05-01
00841447116479Easy Glide Transport Chair for InvacareEGTC19STFSBUEGTC19STFSBU2026-04-10
00841447116486Easy Glide Transport Chair for InvacareEGTC19STFSBKEGTC19STFSBK2026-04-10
00841447116493Easy Glide Transport Chair for InvacareEGTC19STRSBUEGTC19STRSBU2026-04-10
00841447116509Easy Glide Transport Chair for InvacareEGTC19STRSBKEGTC19STRSBK2026-04-10
00841447116516Easy Glide Transport Chair for InvacareEGTC19ALRSBUEGTC19ALRSBU2026-04-10
00841447116523Easy Glide Transport Chair for InvacareEGTC19ALRSBKEGTC19ALRSBK2026-04-10
00841447109754Invacare® Think Soft® Long Term Care Bed Positioning DeviceIHCSTSPD-QSPIHCSTSPD-QSP2026-03-02
00841447116301Easy Glide Wheelchair for InvacareEGWC16STRSBUEGWC16STRSBU2026-02-13
00841447116318Easy Glide Wheelchair for InvacareEGWC16STRSBKEGWC16STRSBK2026-02-13
00841447116325Easy Glide Wheelchair for InvacareEGWC16STREBUEGWC16STREBU2026-02-13
00841447116332Easy Glide Wheelchair for InvacareEGWC16STREBKEGWC16STREBK2026-02-13
00841447116349Easy Glide Wheelchair for InvacareEGWC18STRSBUEGWC18STRSBU2026-02-13
00841447116356Easy Glide Wheelchair for InvacareEGWC18STRSBKEGWC18STRSBK2026-02-13
00841447116363Easy Glide Wheelchair for InvacareEGWC18STREBKEGWC18STREBK2026-02-13
00841447116370Easy Glide Wheelchair for InvacareEGWC18STREBUEGWC18STREBU2026-02-13

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