FDA UDI In Commercial Distribution 🇺🇸 United States

PressureGuard®

DI: H933AP844229 · Model: APM · SPAN-AMERICA MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PressureGuard®
Primary DI
H933AP844229
Version / Model
APM
Catalog Number
AP8442-29
Company Name
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Labeler DUNS
073704413
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-02-11
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
d4e159f7-3658-4862-b7af-efa3af18160b

Device Description

Alternating Pressure Mattress

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FNM Mattress, Air Flotation, Alternating Pressure

GMDN Terms

Code Name
47478 Alternating-pressure bed mattress overlay system

Identifiers

Type ID
Primary H933AP844229