Midmark

Basic Information

• Brand Name: Midmark
• Primary DI: 00841709109201
• Version / Model: 640-011
• Catalog Number: 640-011
• Company Name: MIDMARK CORPORATION
• Labeler DUNS: 005036025
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-16
• Public Version: 3
• Public Version Date: 2021-03-29
• Public Version Status: Update
• Public Device Record Key: 13c82454-e1f6-4033-bdd2-f2754518e343

Device Description

The Midmark 640 Pediatric Exam Table is intended to provide positioning and support of patients for general exam procedures conducted by medical professionals. The intended patient weight is to be between 5lbs - 40lbs. The digital scale is intended for regular monitoring to assess patient weight change, as well as to assist medical diagnosis. The manual infantometer is intended for regular monitoring to assess patient length change, as well as to assist medical diagnosis.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
FRW	SCALE, PATIENT	General Hospital	880.2720	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35324	Infant scale, electronic	An electrically-powered device designed to measure the weight of an infant, particularly a newborn, or to monitor weight changes, e.g., during critical care procedures. It typically consist of a weight tray, a flexure plate or bending beam, an electronic transducer, and an analogue or digital display; it may include markings to also measure infant length. The device is also known as paediatric or baby scale.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841709109201	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal