FDA.report

MEDI-VAC

Primary DI
10630140153563
Brand
MEDI-VAC
Company
Cardinal Health 200, LLC
Model
65652-551
Catalog number
65652-551
Device description
Poly Carb Can 1.5L CRD
Published
2018-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10630140153563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1063014015356310630140153563

GMDN Terms

TermDefinition
Surgical suction system collection container, reusableA cylindrical or bottle-shaped sealable container intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a reusable device.

Device Sizes

TypeValueUnit
Total Volume1500Milliliter

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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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