DEVICE: Protekt Aire (05060488570186)

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Device Identifier (DI) Information

Protekt Aire
94004
94004
PROACTIVE MEDICAL PRODUCTS, LLC
05060488570186
GS1
1
PROTEKT SUPREME SUPPORT SELF ADJUSTING AIR-FOAM MATTRESS 48"
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Height: 7 Inch
Width: 48 Inch
Length: 80 Inch
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Device Status

In Commercial Distribution
August 12, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
No
Yes
No CLOSE

Customer Contact

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+1 855 237 7622
sales@proactivemedical.com
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