FDA.reportPublic FDA data

Sechrist Industries, Inc.

Primary DI
00899660002871
Brand
Sechrist Industries, Inc.
Company
SECHRIST INDUSTRIES, INC.
Model
20558-00
Device description
AIR BREAK BREATHING APPARATUS, ENGLISH, DEMAND FLOW
Published
2023-08-01
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
CBPValve, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K884543000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884543000LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASKSechrist Industries, Inc.1988-12-13CBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899660002871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899660002871008996600028718996600028710899660002871

GMDN Terms#

Term, Definition table
TermDefinition
Demand valveA non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7145798400productinformation@sechristusa.com

Regulatory Flags#

DUNS number
062084215
Device count
1
Lot or batch
true
Manufacturing date on label
true

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

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