DEVICE: Sechrist Industries, Inc. (00085268200710)

Device Identifier (DI) Information

Sechrist Industries, Inc.
XXXXX-2
In Commercial Distribution

SECHRIST INDUSTRIES, INC.
00085268200710
GS1

1
062084215 *Terms of Use
INCORRECT ENTRY
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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

GMDN Preferred Term Name GMDN Definition
Hyperbaric chamber, stationary A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
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FDA Product Code

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Product Code Product Code Name
CBF Chamber, Hyperbaric
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K950386 000
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Sterilization

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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
Weight: 1200 Pound
Height: 51 Inch
Width: 39 Inch
Depth: 99 Inch
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Device Record Status

23283a13-8d26-4581-8a58-4e084794e123
July 06, 2018
3
December 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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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Yes
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Customer Contact

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7145798400
productinformation@sechristusa.com
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