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FDA UDI In Commercial Distribution 🇺🇸 United States

MEAS 4400 Series Temperature Probe

DI: H29744990 · Model: 4499 · MEASUREMENT SPECIALTIES, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

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Basic Information

Brand Name: MEAS 4400 Series Temperature Probe
Primary DI: H29744990
Version / Model: 4499
Catalog Number: 861552
Company Name: MEASUREMENT SPECIALTIES, INC.
Labeler DUNS: 029351079
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-07-01
Public Version: 3
Public Version Date: 2018-10-19
Public Version Status: Update
Public Device Record Key: ba69b54e-0961-48be-946f-7bfd727ddfb5

Device Description

Temperature Probe

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35254	General-purpose patient temperature probe, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H29744992	HIBCC	Carton	10	In Commercial Distribution
Package	H29744991	HIBCC	Case	20	In Commercial Distribution
Primary	H29744990	HIBCC

Customer Contacts

Phone: 800-899-9783
Email: [email protected]

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -5 – 55 Degrees Celsius