FDA.reportPublic FDA data

SAFEDRAW(TM) DT-4812SD

Primary DI
00886333621316
Brand
SAFEDRAW(TM) DT-4812SD
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
682131
Catalog number
682131
Device description
"A 1-way 60 drops with 60"" tube Adset connected to a 3cc transducer. The Safedraw is assembled with a 3cc restricted syringe stops at 2cc, with a 12"" Pressure Tubing from the patient and a 48"" Pressure tubing to the syringe. It also includes a separately packed 2x male protective caps and a Label Set. "
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886333621316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886333621316008863336213168863336213160886333621316

GMDN Terms#

Term, Definition table
TermDefinition
Invasive-pressure external transducer, single-useA sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.

Device Sizes#

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

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
Kit
true
Lot or batch
true
Expiration date on label
true

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10884450360498Merit Medical®108844503604982018-03-19
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