FDA.reportPublic FDA data

Bio-Med Devices, Inc.

Primary DI
00813841020072
Brand
Bio-Med Devices, Inc.
Company
BIO-MED DEVICES, INC.
Model
2000K
Catalog number
2000K
Device description
Air / Oxygen Blender mid flow
Published
2015-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MODAccessory To Continuous Ventilator (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MODAccessory To Continuous Ventilator (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925982000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925982000BMD AIR/OXYGEN BLENDERBiomedical Devices, Inc.1993-10-07BZR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813841020072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813841020072008138410200728138410200720813841020072

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
203-458-0202CUSTSERV@BIOMEDDEVICES.COM

Regulatory Flags#

DUNS number
116167966
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813841020027Bio-Med Devices, Inc.TV-10055002024-12-31
00813841022281Bio-Med Devices, Inc.10300103002023-06-12
00813841022298Bio-Med Devices, Inc.10301103012023-06-12
00813841022304Bio-Med Devices, Inc.2003TR2003TR2023-06-12
00813841021260Bio-Med Devices, Inc.2003P2003P2019-10-04
00813841021277Bio-Med Devices, Inc.2003Q2003Q2019-10-04
00813841021307Bio-Med Devices, Inc.2003U2003U2019-10-04
00813841021567Bio-Med Devices, Inc.2001C2001C2019-10-04
00813841021574Bio-Med Devices, Inc.2003FFE1A2003FFE1A2019-10-04
00813841021581Bio-Med Devices, Inc.2003FFEUA2003FFEUA2019-10-04
00813841021611Bio-Med Devices, Inc.20011PE20011PE2019-10-04
00813841021628Bio-Med Devices, Inc.40011PE40011PE2019-10-04
00813841021635Bio-Med Devices, Inc.80018PE80018PE2019-10-04
00813841021642Bio-Med Devices, Inc.20011NPE20011NPE2019-10-04
00813841020010Bio-Med Devices, Inc.2003GE2003GE2015-11-02
00813841020034Bio-Med Devices, Inc.200120012015-11-02
00813841020041Bio-Med Devices, Inc.200220022015-11-02
00813841020058Bio-Med Devices, Inc.200320032015-11-02
00813841020065Bio-Med Devices, Inc.200420042015-11-02
00813841020089Bio-Med Devices, Inc.2000KM2000KM2015-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00813841022304Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2023-06-12
10840330700198ProcureTwin Med, LLCMOD2022-11-02
30840330700192ProcureTwin Med, LLCMOD2022-11-02
00813841021260Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021277Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021307Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021567Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021574Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021581Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021611Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021628Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021635Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021642Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
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15060120952537Respironics Domed (Gherkin)GVS FILTER TECHNOLOGY UK LTDMOD2016-09-23
15060120952544Tyco-Achieva BulkGVS FILTER TECHNOLOGY UK LTDMOD2016-09-23
15060120952551InogenGVS FILTER TECHNOLOGY UK LTDMOD2016-09-23
25060120952534Respironics Domed (Gherkin)GVS FILTER TECHNOLOGY UK LTDMOD2016-09-23
25060120952541Tyco-Achieva BulkGVS FILTER TECHNOLOGY UK LTDMOD2016-09-23