FDA.reportPublic FDA data

MEAS 4400 Series Temperature Probe

Primary DI
H29744640
Brand
MEAS 4400 Series Temperature Probe
Company
MEASUREMENT SPECIALTIES, INC.
Model
4464
Catalog number
861555
Device description
Foley Catheter Temperature Probe, 14 FR
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZLCatheter, Retention Type, Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921561000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921561000YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBESYsis, Inc.1992-11-23EZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H29744641PackageHIBCC10In Commercial Distribution
H29744642PackageHIBCC10In Commercial Distribution
H29744640PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, single-useA temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge14French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-5 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-899-9783medfeedback@te.com

Regulatory Flags#

DUNS number
029351079
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H29744680MEAS 4400 Series Temperature Probe44688615572016-07-01
H297800106341408001 Series Foley Catheter Temperature Probe8001-063-4148001-063-4142016-07-01
H29744660MEAS 4400 Series Temperature Probe44668615562016-07-01
H297800106341608001 Series Foley Catheter Temperature Probe8001-063-4168001-063-4162016-07-01
H29740091Tempheart40090605342018-09-21
H2974010Reusable GP Temperature Probe4018811012018-09-21
H29740100Extension Cable40100813202018-09-21
H29740121Mini Tempheart40120609852018-09-21
H2974020Reusable GP Temperature Probe4020811022018-09-21
H2974030Reusable Tubular Temperature Probe4030811032018-09-21
H2974060Reusable Tubular Temperature Probe4060811062018-09-21
H297409A0Reusable Skin Temperature Probe409A0812082018-09-21
H297409B0Reusable Skin Temperature Probe409B0812092018-09-21
H2974270Reusable Skin Temperature Probe4270811172018-09-21
H2977010Reusable GP Temperature Probe7018813002018-09-21
H2977290Reusable Skin Temperature Probe7290813122018-09-21
H29744910MEAS 4400 Series Temperature Probe44918615272016-07-01
H29744990MEAS 4400 Series Temperature Probe44998615522016-07-01
H2974499HD0MEAS 4400 Series Temperature Probe4499HD8615532016-07-01
H2974499RJ0MEAS 4400 Series Temperature Probe4499RJ861551TP2016-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483507470Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507487Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507494Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
10192253068221DoverCardinal Health 200, LLCEZL2026-01-15
10192253068238DoverCardinal Health 200, LLCEZL2026-01-15
10192253067651DoverCardinal Health 200, LLCEZL2025-04-14
10192253067668DoverCardinal Health 200, LLCEZL2025-04-14
10192253067675DoverCardinal Health 200, LLCEZL2025-04-14
10192253067682DoverCardinal Health 200, LLCEZL2025-04-14
10192253031423DoverCardinal Health 200, LLCEZL2025-01-15
10192253031409DoverCardinal Health 200, LLCEZL2025-01-14
10192253031416DoverCardinal Health 200, LLCEZL2025-01-14
10192253038897DoverCardinal Health 200, LLCEZL2025-01-14
10192253031140DoverCardinal Health 200, LLCEZL2024-12-20
10192253031164DoverCardinal Health 200, LLCEZL2024-12-20
10192253066203DoverCardinal Health 200, LLCEZL2024-09-04
10192253066210DoverCardinal Health 200, LLCEZL2024-09-04
10192253066227DoverCardinal Health 200, LLCEZL2024-09-04
10192253066234DoverCardinal Health 200, LLCEZL2024-09-04
10192253066241DoverCardinal Health 200, LLCEZL2024-09-04
10192253066258DoverCardinal Health 200, LLCEZL2024-09-04
10192253066265DoverCardinal Health 200, LLCEZL2024-09-04
10192253066272DoverCardinal Health 200, LLCEZL2024-09-04
10192253066289DoverCardinal Health 200, LLCEZL2024-09-04
10192253066296DoverCardinal Health 200, LLCEZL2024-09-04
10192253066302DoverCardinal Health 200, LLCEZL2024-09-04
10192253066319DoverCardinal Health 200, LLCEZL2024-09-04
10192253066326DoverCardinal Health 200, LLCEZL2024-09-04
10192253066333DoverCardinal Health 200, LLCEZL2024-09-04
10192253066340DoverCardinal Health 200, LLCEZL2024-09-04