FDA.reportPublic FDA data

Perry Sigma Monoplace

Primary DI
00852678007092
Brand
Perry Sigma Monoplace
Company
PERRY BAROMEDICAL CORPORATION
Model
Sigma 36 w/Undercarriage
Device description
"HYPERBARIC SYSTEM, 36"" MONOPLACE CHAMBER WITH UNDERCARRIAGE "
Published
2018-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBFChamber, Hyperbaric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBFChamber, HyperbaricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990927000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990927000SIGMA 3400 MONOPLACE HYPERBARIC CHAMBERPerry Baromedical Corp.1999-11-12CBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852678007092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852678007092008526780070928526780070920852678007092

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
Height68.45Inch
Length105Inch
Weight2600Pound
Width42Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-741-4376info@perryhbo.com

Regulatory Flags#

DUNS number
616251443
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852678007016Perry Sigma MonoplaceSigma 342018-03-01
00852678007023Perry Sigma MonoplaceSigma 362018-02-28
00852678007030Perry Sigma MonoplaceSigma 402018-03-01
00852678007085Perry Sigma MonoplaceSigma 40 w/Undercarriage2018-03-01
00852678007108Perry Sigma MonoplaceSigma 34 w/Undercarriage2018-03-01
00852678007078Perry BaromedicalSigma 40-II2022-08-31
00852678007122BaramedBaramed 302022-08-31
00852678007047Perry Sigma MonoplaceSigma 34 Elite2018-03-01
00852678007054Perry Sigma MonoplaceSigma 36 Elite2018-03-01
00852678007061Perry Sigma MonoplaceSigma 40 Elite2018-03-01
00852678007115Perry Sigma MonoplaceSigma 40 Elite w/ Undercarriage2018-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850052737016Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737023Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737030Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737047Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737054Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
00850052737061Sea-Long Medical SystemsSea-Long Medical Systems LLCCBF2026-10-12
G625R8003403Hyperbaric for LifeHyperbaric For Life.com, LlcCBF2026-08-27
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