FDA.reportPublic FDA data

Sechrist Industries, Inc.

Primary DI
00085268200710
Brand
Sechrist Industries, Inc.
Company
SECHRIST INDUSTRIES, INC.
Model
XXXXX-2
Device description
INCORRECT ENTRY
Published
2016-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
CBFChamber, Hyperbaric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBFChamber, HyperbaricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950386000MODEL 3200P/3200PR HYPERBARIC CHAMBERSechrist Industries, Inc.1995-06-13CBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00085268200710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085268200710000852682007100852682007100085268200710

GMDN Terms#

Term, Definition table
TermDefinition
Hyperbaric chamber, stationaryA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth99Inch
Height51Inch
Weight1200Pound
Width39Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7145798400productinformation@sechristusa

Regulatory Flags#

DUNS number
062084215
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850073470091Sechrist Industries, Inc.21709-00U2026-01-27
00850073470084Sechrist Industries, Inc.218812025-10-02
00850073470015Sechrist Industries, Inc.20582-0212025-04-23
00850073470022Sechrist Industries, Inc.20582-S-3112025-04-23
00850073470039Sechrist Industries, Inc.20582-S-2312025-04-23
00850073470046Sechrist Industries, Inc.20582-021-282025-04-23
00899660002253Sechrist Industries, Inc.21762-010-36H2016-12-12
00899660002260Sechrist Industries, Inc.21762-0112016-12-12
00899660002277Sechrist Industries, Inc.21762-1102016-12-12
00899660002284Sechrist Industries, Inc.21762-110-33H2016-12-12
00899660002291Sechrist Industries, Inc.21762-110-36H2016-12-12
00899660002307Sechrist Industries, Inc.21762-110-41H2016-12-12
00899660002314Sechrist Industries, Inc.21762-111-36H2016-12-12
00899660002321Sechrist Industries, Inc.21762-1242016-12-12
00852682007064Sechrist Industries, Inc.21762-1112016-12-12
00899660002000Sechrist Industries, Inc.3300H-H-01-12017-06-02
00899660002017Sechrist Industries, Inc.3300H-00-02016-12-12
00899660002024Sechrist Industries, Inc.3300H-00-12016-12-12
00899660002031Sechrist Industries, Inc.3300H-01-12016-12-12
00899660002048Sechrist Industries, Inc.3300HR-00-12016-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860006478988HMS-5000-6-MINI-QUADROHyperbaric Modular Systems Inc.CBF2026-05-05
08906124945116TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2026-04-30
08906124945123TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2026-04-30
08906124944713TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2026-02-12
G625R8003410Hyperbaric for LifeHyperbaric For Life.com, LlcCBF2025-08-20
00850011262016PCCI Hyperbaric SystemsPCCI HYPERBARIC SYSTEMSCBF2025-07-14
00860006478919HMS-5000Hyperbaric Modular Systems Inc.CBF2025-06-16
G625R800340Hyperbaric for LifeHyperbaric For Life.com, LlcCBF2025-06-02
08906124943051TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2025-05-04
08906124943068TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2025-05-04
G623430US Hyperbaric NetworkUS Hyperbaric Network LLCCBF2025-05-02
00850052737009Sea-Long Medical HoodSea-Long Medical Systems LLCCBF2024-11-21
08906124941477TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2024-09-03
00852834007003Newtowne Tent ChamberTYPHOON WATER WARES LTDCBF2024-05-28
B878430F0RevitalairOXAVITA S.R.L.CBF2024-01-19
08906124940012TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2024-01-10
08906124940005TEKNA Manufacturing Pvt. Ltd.TEKNA MANUFACTURING PRIVATE LIMITEDCBF2023-09-29
00850011262009PCCI Hyperbaric SystemsPCCI HYPERBARIC SYSTEMSCBF2023-08-07
00860006478940HMS-2000 Hyperbaric Modular Systems Inc.CBF2023-08-02
00860006478964HMS-1000Hyperbaric Modular Systems Inc.CBF2023-08-02
00860006478926HMS-4000Hyperbaric Modular Systems Inc.CBF2023-08-01
00860006478902HMS-5000-COMPACT-QUADROHyperbaric Modular Systems Inc.CBF2022-10-31
00852678007078Perry BaromedicalPERRY BAROMEDICAL CORPORATIONCBF2022-08-31
00852678007122BaramedPERRY BAROMEDICAL CORPORATIONCBF2022-08-31
00852682007996Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2022-08-29
00852682007941Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-06-26
00852682007958Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-06-26
00852682007934Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-05-01
00852834007065Newtowne HyperbaricsTYPHOON WATER WARES LTDCBF2020-03-13
00852682007903Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.CBF2020-02-01