AccessGUDID - DEVICE: PROVIDENCE HOSPITAL - ONE LINE SET (00886333680757)

GUDID

Device Identifier (DI) Information

Brand Name: PROVIDENCE HOSPITAL - ONE LINE SET
Version or Model: 688075
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 688075
Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Primary DI Number: 00886333680757
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595138793 *Terms of Use

Device Description: 1-way 20 drops, 60" Adset connected with a 3cc Transducer. The blood sampling line has a 24" Small Bore tube , a 1-way stopcock and another 6" small bore tube connect to the Septum Device. The other end of the device connects to a 3-way Red and a 3-way White stopcocks , a 6" Pressure Tubing which cis connected to a 5cc Restricted Syringe with touchguard stops at 3cc.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31336	Arterial blood sampling kit	A collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, Measurement, Blood-Pressure, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3cc transducer

Device Record Status

Public Device Record Key: b1434ee9-9bbd-498b-972a-cdecbeec9fd4
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016