AccessGUDID - DEVICE: SURFLO (06927675506849)

GUDID

Device Identifier (DI) Information

Brand Name: SURFLO
Version or Model: SV*S25BLSE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SV*S25BLSE
Company Name: Terumo Medical Products (Hangzhou) Co., Ltd.

Primary DI Number: 06927675506849
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544830912 *Terms of Use

Device Description: SURFLO Winged Infusion Set with Needle Protection

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":	Yes
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Scalp vein intravenous administration set	A collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container into a patient's scalp vein. It typically includes tubing, connectors, chambers, clamps, and specialized needles to access scalp veins. The device is normally intended for use on paediatric patients, especially infants. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
FPA	Set, administration, intravascular

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

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Storage and Handling
Special Storage Condition, Specify: Do not store at extreme temperature and humidity.Fragile, handle with care. Keep away from heat. Keep dry .

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Type: Thin Wall (TW)
Length: 0.75 Inch
Total Volume: 0.19 Milliliter
Needle Gauge: 25 Gauge
Device Size Text, specify: Tubing Length:3.5inch

Device Record Status

Public Device Record Key: 628f35f1-341b-4609-8798-adc339703119
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 12, 2016