Bio-Med Devices, Inc.

Primary DI
00813841020744
Brand
Bio-Med Devices, Inc.
Company
BIO-MED DEVICES, INC.
Model
CROSSVENT
Catalog number
4400BEC
Device description
Ventilator, Transport
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
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942938000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942938000CROSSVENT-4 VENTILATORBio-Med Devices, Inc.1995-09-19CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813841020744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813841020744008138410207448138410207440813841020744

GMDN Terms#

Term, Definition table
TermDefinition
Transport electric ventilatorAn electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.

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

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