FDA.reportPublic FDA data

Sechrist Industries, Inc.

Primary DI
00899660002888
Brand
Sechrist Industries, Inc.
Company
SECHRIST INDUSTRIES, INC.
Model
20558-01
Device description
AIR BREAK BREATHING APPARATUS, ASSY, FREE 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
00899660002888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899660002888008996600028888996600028880899660002888

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing valve, reusableA non-sterile device that is a one-way valve used to direct the flow of breathing gases and prevent the patient rebreathing the exhaled gases. It is typically used in a breathing system or between an oxygen mask and its reservoir bag. The device may be of various designs and will typically include unidirectional valves made of, e.g., silicone, rubber, metal, mica, sheets or discs that open and close for each inspiration/expiration. 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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Primary DI, Brand, Company table
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