FDA.reportPublic FDA data

SP5555-POLE MOUNTING BRACKET

Primary DI
50886333621618
Brand
SP5555-POLE MOUNTING BRACKET
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
682161
Catalog number
682161
Device description
holder
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRBProbe, Thermodilution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRBProbe, ThermodilutionCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50886333621618PackageGS150In Commercial Distribution
00886333621613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633362161850886333621618
00886333621613008863336216138863336216130886333621613

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure transducer holderA device used to secure a pressure transducer used for invasive blood pressure measurement at a desired height. The holder can be fastened to (e.g., a bed or an operating table) and can be adjusted so that the transducer is at the same level as the heart of the patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
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

Other Devices From This Company#

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10884450363956RadialFlo™108844503639562019-02-28
10884450322557Meritrans DTXPlus®108844503225572018-01-26
10884450322564Meritrans DTXPlus®108844503225642018-01-26
10884450323905Critiflo™108844503239052018-01-30
10884450326463Merit Medical®108844503264632018-01-26
10884450360467Merit Medical®108844503604672018-08-06
10884450360474Merit Medical®108844503604742018-12-13
10884450360481Merit Medical®108844503604812018-09-10
10884450360498Merit Medical®108844503604982018-03-19
10884450360504Merit Medical®108844503605042018-05-22
10884450360511Merit Medical®108844503605112018-09-17
10884450360535Meritrans DTXPlus®108844503605352018-12-03
10884450360689Meritrans DTXPlus®108844503606892018-02-14
10884450360702Meritrans DTXPlus®108844503607022018-11-06
10884450360764Meritrans DTXPlus®108844503607642018-04-11
10884450360825Meritrans DTXPlus®108844503608252018-05-01
10884450371753Meritrans DTXPlus®108844503717532019-10-11

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