FDA.reportPublic FDA data

Blender

Primary DI
10846446063813
Brand
Blender
Company
Carefusion Corporation
Model
11391-PMN
Catalog number
11391-PMN
Device description
KIT,MICROBLENDER MOUNTING BRACKET
Published
2017-06-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K883038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K883038000P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDERBird Products Corp.1988-11-16BZR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846446063813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084644606381310846446063813

GMDN Terms#

Term, Definition table
TermDefinition
Transportable medical equipment stand, non-poweredA non-powered (non-active) transportable device [e.g., on wheels or easily movable] designed to support medical equipment used for clinical purposes [e.g., in an operating room and/or an examination/treatment room]. It may include manually-adjustable articulated arms to enable dynamic positioning of equipment; the equipment to be supported is not included. The device does not include a battery pack but might include a battery holder and electrical connection wiring to feed power to medical equipment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.231.2466support.smcvent.us@carefusion.com

Regulatory Flags#

DUNS number
830432451
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403296864enFlow980304VS30980304VS302016-09-21
10846446001693Vela11571115712017-06-23
10885403272424AirLife6098ADPG6098ADPG2016-09-01
10885403272431AirLife6098DPG6098DPG2016-09-01
10885403001024AirLife5007P5007P2016-09-01
10885403006425AirLife0020020020022016-09-01
10885403006524AirLife0024300024302016-09-01
10885403006531AirLife0024310024312016-09-01
10885403006548AirLife0024330024332016-09-01
10885403006555AirLife0024340024342016-09-01
10885403006562AirLife0024350024352016-09-01
10885403006579AirLife0024380024382016-09-21
10885403006586AirLife0024430024432016-09-01
10885403006593AirLife0024440024442016-09-01
10885403010958AirLife0024460024462016-09-01
10885403010996AirLife0025010025012016-09-01
10885403011726AirLife0016180016182016-09-01
10885403026980AirLife6200-5046200-5042016-09-01
10885403027079AirLife6934-5046934-5042016-09-01
10885403039072AirLife0021730021732016-09-01

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Primary DI, Brand, Company table
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