Valleylab

Basic Information

• Brand Name: Valleylab
• Primary DI: 10884521782631
• Version / Model: E10503
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-02
• Public Version: 5
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 6b05a4bf-f456-4247-bd46-c78a0a5ff87b

Device Description

Monopolar Cord

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: 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: 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
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47143	Electrical-only medical device connection cable, single-use	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521782638	GS1	CASE	50	In Commercial Distribution
Primary	10884521782631	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193004	000

Device Sizes

Type	Value	Unit	Text
Length	10	Feet

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -22 – 140 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry