FDA.reportPublic FDA data

8001 Series Foley Catheter Temperature Probe

Primary DI
H29780010634160
Brand
8001 Series Foley Catheter Temperature Probe
Company
MEASUREMENT SPECIALTIES, INC.
Model
8001-063-416
Catalog number
8001-063-416
Device description
8001 Series Foley Catheter Temperature Probe, 16 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
H29780010634161PackageHIBCC10In Commercial Distribution
H29780010634162PackageHIBCC10In Commercial Distribution
H29780010634160PrimaryHIBCC0

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 Gauge16French

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
H29744640MEAS 4400 Series Temperature Probe44648615552016-07-01
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
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
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08886483507487Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507494Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
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