AccessGUDID - DEVICE: PMI Probasics® (00841447104070)

GUDID

Device Identifier (DI) Information

Brand Name: PMI Probasics®
Version or Model: SA901P
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SA901P
Company Name: COMPASS HEALTH BRANDS CORP.

Primary DI Number: 00841447104070
Issuing Agency: GS1
Commercial Distribution End Date: February 20, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 827221698 *Terms of Use

Device Description: APP (Pads only)

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):	Yes
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?
47476	Air-filled bed mattress overlay	A static-air-inflated pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNM	Mattress, Air Flotation, Alternating Pressure

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: acafb1cf-9563-44ff-a45f-9ab66b2709ce
Public Version Date: February 21, 2024
Public Version Number: 4
DI Record Publish Date: September 23, 2016