BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Alaris, Turbo Temp, Turbo Temp Plus

DI: 10885403229909 · Model: P850A · BD Switzerland Sàrl

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: Alaris, Turbo Temp, Turbo Temp Plus
Primary DI: 10885403229909
Version / Model: P850A
Catalog Number: P850A
Company Name: BD Switzerland Sàrl
Labeler DUNS: 482631558
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-22
Public Version: 6
Public Version Date: 2024-08-14
Public Version Status: Update
Public Device Record Key: a17f402e-d39f-4799-b141-060bfcb8e5f5

Device Description

Alaris Tri-Site, Turbo Temp and Turbo Temp Plus II Probe Covers

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: No
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
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
13116	Electronic thermometer probe cover	A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10885403229909	GS1
Package	20885403229906	GS1	Shelfpack	200	In Commercial Distribution

Customer Contacts

Phone: +1(844)823-5433
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K860436	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -40 – 125 Degrees Fahrenheit