FDA.report

CARDINAL HEALTH

Primary DI
10885380072369
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
K84
Catalog number
K84
Device description
Medi Vac Yankauer Suction Handle with Tapered Bulbous Tip and Non-Conductive Suction Tubing 6 mm x 2.7 m (9 ft.)
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GAZTUBING, NONINVASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885380072367PackageGS125In Commercial Distribution
10885380072369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088538007236750885380072367
1088538007236910885380072369

GMDN Terms

TermDefinition
Surgical/emergency suction cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.

Device Sizes

TypeValueUnit
Length9Feet
Lumen/Inner Diameter0.24Inch

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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