FDA.reportPublic FDA data

Safedraw™

Primary DI
10884450356408
Brand
Safedraw™
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
B
Catalog number
689369
Published
2026-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DSKCOMPUTER, BLOOD-PRESSURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSKComputer, Blood-PressureCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450356405PackageGS14In Commercial Distribution
10884450356408PrimaryGS10
00884450356401Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445035640520884450356405
1088445035640810884450356408
00884450356401008844503564018844503564010884450356401

GMDN Terms#

Term, Definition table
TermDefinition
Invasive blood pressure transducer setA collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device 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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
595138793
Device count
5
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884450372965Safedraw™B6880772026-10-07
10884450480615Safedraw™B6889962026-10-07
10884450321505Careflow™10884450321505681631/A2022-09-20
10884450321567Careflow™108844503215672018-07-19
10884450321598Careflow™108844503215982018-07-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450372965Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DSK2026-10-07
00198953009567Carescape ONEGE Healthcare Finland OyDSK2026-10-04
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDSK2026-04-15
00191506052454MDU5 Plus™BOSTON SCIENTIFIC CORPORATIONDSK2025-12-09
00850022994456Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994463Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994470Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994487Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994524Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00850022994531Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00850022994548Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00850022994555Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00883873760420ASSY,CABLE,ADAPTER,TEMPERATURE,M-PAK,LP35,10FTPHYSIO-CONTROL, INC.DSK2025-09-26
00883873760437ASSY, CABLE, ADAPTER, TEMP, LP35, 6FT,IRONGANPHYSIO-CONTROL, INC.DSK2025-09-26
00883873760444ASSY, CABLE, ADAPTER, IP, ICU, LP35PHYSIO-CONTROL, INC.DSK2025-09-26
00883873760451ASSY, CABLE, ADAPTER, IP, EDWARDS, LP35PHYSIO-CONTROL, INC.DSK2025-09-26
00850022994401Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-09-08
00845225012984Patient Interface Module (PIMr)Philips Image Guided Therapy CorporationDSK2025-08-22
00845225011420Patient Interface Module (PIMr)Philips Image Guided Therapy CorporationDSK2025-03-24
00845225012762IVUS-PIMPhilips Image Guided Therapy CorporationDSK2025-03-24
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSK2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSK2024-12-19
00847946080525PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080532PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080563PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080570PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080587PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080600PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080617PROPAQ MZoll Medical CorporationDSK2024-03-06
00847946080648PROPAQ MZoll Medical CorporationDSK2024-03-06