DEVICE: SIMMONS Clinical Care (M368765000S1)
Device Identifier (DI) Information
SIMMONS Clinical Care
765000S
In Commercial Distribution
GF HEALTH PRODUCTS, INC.
765000S
In Commercial Distribution
GF HEALTH PRODUCTS, INC.
Clinical Sensor Plus Alternating Pressure Mattress System
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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47478 | Alternating-pressure bed mattress overlay system |
An assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, 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.
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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 [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -15 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bcdd560e-40dd-4194-a18f-4b3369e0831b
July 25, 2019
3
August 31, 2016
July 25, 2019
3
August 31, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
M368765000S2 | 2 | M368765000S1 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
770-368-4700
cs@grahamfield.com
cs@grahamfield.com