FDA.report

BA 1/2 KIT,WE,P37,INL,2',DP

Primary DI
00840828137331
Brand
BA 1/2 KIT,WE,P37,INL,2',DP
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
BCC-5002-A02-001
Catalog number
16832
Device description
BA 1/2 KIT,WE,P37,INL,2',DP
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IQASystem, Environmental Control, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840828137331PrimaryGS10

GMDN Terms

TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-235-7500mwinter@curbell.com

Regulatory Flags

DUNS number
796452311
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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