DEVICE: SofCare (07613327175141)
Device Identifier (DI) Information
SofCare
2780-600-000
In Commercial Distribution
2780-600-000
STRYKER CORPORATION
2780-600-000
In Commercial Distribution
2780-600-000
STRYKER CORPORATION
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
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? |
---|---|---|---|---|
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IOQ | BED, FLOTATION THERAPY, POWERED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between -40 and 140 Degrees Fahrenheit |
Storage Environment Temperature: between -40 and 140 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c545fcd0-606c-400d-8b89-157c736a3cc2
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 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 |
---|---|---|---|---|---|
57613327175146 | 4 | 07613327175141 | In Commercial Distribution | case |
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
[?]
No Customer Contact currently defined