DEVICE: NA (04713616092807)
Device Identifier (DI) Information
NA
S2509-7170
In Commercial Distribution
CARILEX MEDICAL, INC.
S2509-7170
In Commercial Distribution
CARILEX MEDICAL, INC.
Airrapy Bairrapy 360 LAL Blanket Aeotex
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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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? |
---|---|---|---|---|
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0995539b-913b-4bae-bea0-12f2e75cdf17
March 29, 2018
2
March 22, 2017
March 29, 2018
2
March 22, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
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