FDA.report

Sechrist Industries, Inc.

Primary DI
00852682007132
Brand
Sechrist Industries, Inc.
Company
SECHRIST INDUSTRIES, INC.
Model
3000
Device description
VENT,HBO,MODEL HV-500A
Published
2016-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CBFChamber, Hyperbaric

Product Code Classifications

CodeDeviceSpecialtyClass
CBFChamber, HyperbaricAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00852682007132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00852682007132008526820071328526820071320852682007132

GMDN Terms

TermDefinition
Neonatal intensive-care ventilatorA mains electricity (AC-powered) automatic cycling device intended for short-term and long-term ventilatory support for a neonatal/paediatric patient, especially those preterm and critically ill with respiratory failure in a critical care setting. It is typically a time-cycled, pressure-control device that includes a small bore flexible tube breathing system. It may be capable of high frequency oscillatory ventilation in addition to conventional ventilation, and includes positive end-expiratory pressure (PEEP) and continuous positive airway pressure (CPAP) controls.

Device Sizes

TypeValueUnit
Depth16Inch
Height23Inch
Weight28Pound
Width18Inch

Sterilization Methods

Method

Contacts

PhoneEmail
7145798400productinformation@sechristusa.com

Regulatory Flags

DUNS number
062084215
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
00850073470091Sechrist Industries, Inc.21709-00U2026-01-27
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
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
00899660002055Sechrist Industries, Inc.3300HR-01-02016-12-12
00899660002062Sechrist Industries, Inc.3300HR-01-12016-12-12
00899660002079Sechrist Industries, Inc.3600H-00-02016-12-12
00899660002086Sechrist Industries, Inc.3600H-00-12016-12-12
00899660002093Sechrist Industries, Inc.3600H-01-02016-12-12
00899660002109Sechrist Industries, Inc.3600H-01-12016-12-12
00899660002116Sechrist Industries, Inc.3600HR-00-02016-12-12
00899660002123Sechrist Industries, Inc.3600HR-00-12016-12-12
00899660002130Sechrist Industries, Inc.3600HR-01-02016-12-12
00899660002147Sechrist Industries, Inc.3600HR-01-12016-12-12

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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
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00866014000302Baramed Hyperbaric ChamberENVIRONMENTAL TECTONICS CORPORATIONCBF2019-01-25
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