FDA.report

SICU ANESTHESIA SET

Primary DI
50886333671002
Brand
SICU ANESTHESIA SET
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
687100
Catalog number
687100
Device description
A single 3cc transducer connected to a 20 drops, 60" tube Adset. The patient line is connected with a 48" pressure tube and a 12" pressure tube via 3-way White stopcocks.
Published
2016-09-22
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
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications

CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50886333671002PackageGS125In Commercial Distribution
00886333671007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633367100250886333671002
00886333671007008863336710078863336710070886333671007

GMDN Terms

TermDefinition
Invasive blood pressure monitoring tubing setA collection of devices that includes the necessary tubing and other items, e.g., connectors, stopcock(s), clamps and filters, used as an external connection for invasive blood pressure measurement. This set will interface, either directly or from an intermediate stopcock, between the applied invasive catheter and the measuring transducer. It will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags

DUNS number
595138793
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
false
Sterilization required before use
false

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