DEVICE: Sechrist Industries, Inc. (00852682007668)

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Device Record History
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Device Identifier (DI) Information
Sechrist Industries, Inc.
3300HP-00-1
In Commercial Distribution

SECHRIST INDUSTRIES, INC.
00852682007668
GS1

1
062084215 *Terms of Use
3300HP CHMBR.ASSY. 33IN.ENGLISH BLUE, STORAGE
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
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?
12061 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CBF Chamber, Hyperbaric
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K140559 000
No 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
Weight: 2030 Pound
Height: 77 Inch
Width: 53 Inch
Depth: 103 Inch
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Device Record Status
7446fd90-5e1c-4477-a102-98efc53e5d42
January 25, 2024
3
June 01, 2018
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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
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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
7145798400
productinformation@sechristusa.com
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