FDA.reportPublic FDA data

Bio-Med Devices, Inc.

Primary DI
00813841022281
Brand
Bio-Med Devices, Inc.
Company
BIO-MED DEVICES, INC.
Model
10300
Catalog number
10300
Device description
OxyMinder oxygen monitor
Published
2023-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213948000OxyMinderBio-Med Devices, Inc.2022-03-17CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813841022281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813841022281008138410222818138410222810813841022281

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory oxygen monitor, battery-poweredA battery-powered instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting (e.g., O2 in an anaesthesia or ventilator breathing circuit, oxygen tent, oxygen therapy device/system tubing). It typically consists of an electronic unit with a display to show actual values of percentage of O2 concentration, a sensor to detect the O2 values, control knobs or buttons, and an alarm to alert when O2 values are beyond a predetermined range.

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
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
00813841020072Bio-Med Devices, Inc.2000K2000K2015-11-02
00813841020089Bio-Med Devices, Inc.2000KM2000KM2015-11-02

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Primary DI, Brand, Company table
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10889483588673Vital Signs™AirLife Finland OyCCL2025-03-31
10889483588697Vital Signs™AirLife Finland OyCCL2025-03-31
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
00817770025856MaxBlend2MAXTEC, LLCCCL2024-08-14
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCCL2024-05-13
10190752191235Vital Signs™AirLife Finland OyCCL2023-05-30
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCCL2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyCCL2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyCCL2023-04-19
00195278524089NAGE Healthcare Finland OyCCL2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyCCL2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyCCL2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyCCL2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682104302NAGE Healthcare Finland OyCCL2022-03-07
10190752111349Vital Signs™Vyaire GmbHCCL2021-04-02
10190752143777Vital Signs™AirLife Finland OyCCL2021-03-05
10190752143784Vital Signs™AirLife Finland OyCCL2021-03-05
10190752143791Vital Signs™AirLife Finland OyCCL2021-03-05
10190752140844Vital Signs™AirLife Finland OyCCL2021-01-28
10190752140912Vital Signs™AirLife Finland OyCCL2021-01-28
10190752141827Vital Signs™AirLife Finland OyCCL2021-01-28