AmerisourceBergen

Basic Information

• Brand Name: AmerisourceBergen
• Primary DI: 00368001110037
• Version / Model: 11003
• Company Name: BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
• Labeler DUNS: 985523874
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2018-05-31
• Public Version: 1
• Public Version Date: 2018-07-02
• Public Version Status: New
• Public Device Record Key: e3794204-fd6f-4323-9f53-77b56de3db3b

Device Description

Thermometer probe covers

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
Package	60368001110039	GS1	Outer Case	4	In Commercial Distribution
Package	20368001110031	GS1	Inner case	14	In Commercial Distribution
Primary	00368001110037	GS1
Unit of Use	80368001110033	GS1