AccessGUDID - DEVICE: ARMEDICA (B866MAMSP25721)

GUDID

Device Identifier (DI) Information

Brand Name: ARMEDICA
Version or Model: AMSP2572
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AMSP2572
Company Name: ARMEDICA MANUFACTURING CORP.

Primary DI Number: B866MAMSP25721
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018941711 *Terms of Use

Device Description: STEEL, ELECTRIC, PEDESTAL MOUNT, ONE SECTION, 25 IN WIDE CHANGING TABLE WITH LAMINATED TOP BUT NO CASTERS

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?
43544	Nappy changing table, stationary	A raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off) mounted on a fixed frame with legs designed to support an infant, child or an adult during nappy (diaper) changing. The device is used primarily for a patient with a disability who is incontinent and require regular changing of their nappies. It is designed to be stationary and is used in one location.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INQ	Table, Powered

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f95e118b-0a62-427c-8fb6-66405d395589
Public Version Date: November 28, 2022
Public Version Number: 1
DI Record Publish Date: November 18, 2022