FDA.report

Kangaroo

Primary DI
10885380182914
Brand
Kangaroo
Company
Cardinal Health 200, LLC
Model
385492
Catalog number
385492
Device description
Kangaroo OMNI Pole Clamp
Published
2024-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LZHPump, infusion, enteral

Product Code Classifications

CodeDeviceSpecialtyClass
LZHPump, Infusion, EnteralGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885380182914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088538018291410885380182914

GMDN Terms

TermDefinition
Frame/rail/pole device holderA clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

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

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