FDA.report

Bio-Med Devices, Inc.

Primary DI
00813841020003
Brand
Bio-Med Devices, Inc.
Company
BIO-MED DEVICES, INC.
Model
MVP-10
Catalog number
2010
Device description
Infant Ventilator, pneumatic
Published
2015-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications

CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813841020003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813841020003008138410200038138410200030813841020003

GMDN Terms

TermDefinition
Portable pneumatic ventilatorA pneumatically-powered, lightweight device that is easily moved/mounted and used to provide long-term alveolar ventilation support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through an endotracheal (ET) tube, tracheostomy cannula, or mask. It includes a control system and alarms, sometimes with additional features (e.g., humidification). Several methods of cycling and ventilation modes may be used. It is typically used in the home, but may also be used in an extended care facility, and/or by emergency medical services (EMS).

Sterilization Methods

Method

Contacts

PhoneEmail
203-458-0202CUSTSERV@BIOMEDDEVICES.COM

Regulatory Flags

DUNS number
116167966
Device count
1
DM exempt
false
Premarket exempt
true
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

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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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00850057117448Green Oxygen Hose, 8ftCORVENT MEDICAL, INCCBK2026-01-06
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00850057117462Cart, IV Power StripCORVENT MEDICAL, INCCBK2026-01-06
00850057117479Cart, IV Power Strip MountCORVENT MEDICAL, INCCBK2026-01-06
00850057117486Patient Circuit Arm ClipCORVENT MEDICAL, INCCBK2026-01-06
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