Refurbished BodyGuard® 121 Pole Mount Charger with DC

Basic Information

• Brand Name: Refurbished BodyGuard® 121 Pole Mount Charger with DC
• Primary DI: B101150317TSR0
• Version / Model: 150-317TSR
• Company Name: CME AMERICA LLC
• Labeler DUNS: 002125419
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 6
• Public Version Date: 2022-09-23
• Public Version Status: Update
• Public Device Record Key: a67af260-cdc2-490f-801b-1493928de9ed
• Distribution End Date: 2020-03-20

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
FRN	Pump, Infusion	General Hospital	880.5725	2
MEA	Pump, Infusion, Pca	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17634	Bedside infusion pump, multichannel	An electrically-powered, non-ambulatory (bedside) device designed to facilitate the simultaneous, accurate, and consistent administration of multiple drugs/solutions (multichannel) from a standard infusion bag or bottle, via intravenous, subcutaneous, arterial, epidural, and intracavital routes, using a dedicated infusion set. It is not dedicated to a specific treatment type and is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B101150317TSR0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K042696	000