BV Medical

Basic Information

• Brand Name: BV Medical
• Primary DI: 00845821031426
• Version / Model: 80-510-214-BC-OTO-L
• Company Name: BV Medical
• Labeler DUNS: 105932508
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-03
• Public Version: 4
• Public Version Date: 2022-09-23
• Public Version Status: Update
• Public Device Record Key: 8fcf113a-677a-4163-9d04-a91967056432

Device Description

Combo Kit: Pink Breast Cancer Awareness Nurse Kit: 30-510-214 Gem-Scope, Adult, Pink, Latex Free, Breast Cancer Chest piece: 60-840-210-HP 2.5 V Standard Otoscope w/specula: 60-402-210-1 Penlight, Disposable, Pink, With Pupil Gauge, Single: 8-380J Fiberglass Tape Measure, BV Logo Sticker, White Case: 80-170-310 Utility scissors 5.5", stainless steel with neon pink handle: Nurse Kit Pocket Organizer, White, Latex Free: 2 Velcro Tab, Fuchsia, Latex Free: 3D Pedometer: Tracks steps, aerobic steps, distance, calories burned. With 7 day memory and clock

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	878.4800	1
LRW	Scissors, General, Surgical	General, Plastic Surgery	878.4800	1
LDE	Stethoscope, Manual	Cardiovascular	870.1875	1
KYT	Light, Examination, Medical, Battery Powered	General Hospital	880.6350	1
ERA	Otoscope	Ear, Nose, Throat	874.4770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37743	Tape measure, reusable	A flexible device intended to be used in a clinical setting to establish an accurate measurement of length greater than a standard ruler (e.g., the girth of a patient's waist or thigh, or the length of a leg). It is typically made of oilcloth or pliable steel and marked in units of length (i.e., inches and/or millimetres). It is usually available as a roll which may be encased in a holder. This is a reusable device.	No	Active
38727	General-purpose surgical scissors, reusable	A hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.	No	Active
13755	Mechanical stethoscope	A mechanical listening device designed for listening to sounds from the heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the users ears. Mechanical stethoscopes are typically found in two variants 1) a general-purpose stethoscope used for clinical/ward activities; or 2) a reinforced stethoscope used by cardiologists.	No	Active
38832	Hand-held examination/treatment light	A small hand-held battery-powered light intended to beused as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. This is a reusable device.	No	Active
12849	Otoscope, direct	An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845821031426	GS1

Customer Contacts

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