FDA.report

Sechrist Industries, Inc.

Primary DI
00852682007163
Brand
Sechrist Industries, Inc.
Company
SECHRIST INDUSTRIES, INC.
Model
3500CP-GL
Device description
LOANER,MIXER,GENERAL
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
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications

CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00852682007163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00852682007163008526820071638526820071630852682007163

GMDN Terms

TermDefinition
Oxygen/air breathing gas mixer, hospitalAn independent mechanical device designed for accurate mixing of air and oxygen (O2) with O2 concentrations ranging from 21% to 100% (oxygen/air proportioner) that are appropriated for breathing in patients who need a concentration of O2 above the normal concentration in air. The mixer receives air and oxygen from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. The mixer may deliver the gas to the patient through devices such as ventilators, tracheostomy tubes, endotracheal (ET) tubes, oxygen tents, and/or masks.

Device Sizes

TypeValueUnit
Depth5Inch
Height6Inch
Weight3Pound
Width4Inch

Sterilization Methods

Method

Contacts

PhoneEmail
7145798400productinformation@sechristusa.com

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 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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