FDA.report

Kangaroo

Primary DI
10885380198885
Brand
Kangaroo
Company
Cardinal Health 200, LLC
Model
1000NT-BM
Catalog number
1000NT-BM
Device description
Kangaroo NTrainer Battery Mount
Published
2025-03-12
Public version status
New
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
HCCDevice, biofeedback

Product Code Classifications

CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885380198885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088538019888510885380198885

GMDN Terms

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 (e.g., monitors, pumps, consoles) 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

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
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

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