AccessGUDID - DEVICE: Midmark (00841709109195)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark
Version or Model: 640-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 640-002
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709109195
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRW	SCALE, PATIENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -25 and 60 Degrees Celsius
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -25 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a88036b4-616e-4464-a76f-5f5d28bbcf80
Public Version Date: May 05, 2020
Public Version Number: 2
DI Record Publish Date: August 16, 2018