FDA.report

Cardiac Output Bridge

Primary DI
20886333201598
Brand
Cardiac Output Bridge
Company
ARGON MEDICAL DEVICES, INC.
Model
041400350A
Catalog number
041400350A
Device description
Cardiac Output Bridge
Published
2016-09-10
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

Contact Domains

Product Codes

CodeName
DRSTransducer, Blood-Pressure, Extravascular

Product Code Classifications

CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20886333201598PackageGS110In Commercial Distribution
00886333201594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633320159820886333201598
00886333201594008863332015948863332015940886333201594

GMDN Terms

TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags

DUNS number
140727624
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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