AccessGUDID - DEVICE: SURFLASH (34987350709869)

GUDID

Device Identifier (DI) Information

Brand Name: SURFLASH
Version or Model: SR*FNP2032
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TERUMO CORPORATION

Primary DI Number: 34987350709869
Issuing Agency: GS1
Commercial Distribution End Date: August 29, 2018
Device Count: 50
Labeler D-U-N-S® Number*: 690543319 *Terms of Use

Device Description: SURFLASH safety I.V. catheter

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	No
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?
40601	Peripheral vascular catheter	A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days

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
Special Storage Condition, Specify: Stacking limit by 5, Keep away from sunlight, Fragile, handle with care, Keep dry
Special Storage Condition, Specify: Do not store at extreme temperature and humidity.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Catheter Gauge 20 Gauge
Length: 1.25 Inch

Device Record Status

Public Device Record Key: 98fe3863-8756-4ef4-8db0-97700e87c52d
Public Version Date: September 14, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016