DEVICE: American Bantex (00092237606834)

Device Identifier (DI) Information

American Bantex
90082
In Commercial Distribution

COMPASS HEALTH BRANDS CORP.
00092237606834
GS1

1
827221698 *Terms of Use
Legacy Pro Pump Replacement
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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 pump A mains electricity (AC-powered) device that forces ambient air into the parallel chambers of an alternating-pressure bed mattress overlay or an alternating-pressure chair cushion, for the timed alternation of chamber inflation and thereby exchange of patient contact points. The pump, which may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient.
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FDA Product Code

[?]
Product Code Product Code Name
FNM Mattress, Air Flotation, Alternating Pressure
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

f89c48aa-bb6e-46ac-a235-151ec7615b21
March 29, 2018
2
October 06, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30092237606835 4 00092237606834 In Commercial Distribution CA
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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

[?]
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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
440-572-1962
CustomerService@compasshealthbrands.com
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