AccessGUDID - DEVICE: SURFLO (36927675515422)

GUDID

Device Identifier (DI) Information

Brand Name: SURFLO
Version or Model: SV*19BLK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SV*19BLK
Company Name: Terumo Medical Products (Hangzhou) Co., Ltd.

Primary DI Number: 36927675515422
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 544830912 *Terms of Use

Device Description: SURFLO Winged Infusion Set

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65416	Basic intravenous administration set, invasive	A collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, Administration, Intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221411	000

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: " DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 19 Gauge
Device Size Text, specify: Type: Thin Wall (TW)
Device Size Text, specify: Tubing Length:12inch
Total Volume: 0.45 Milliliter
Length: 0.75 Inch

Device Record Status

Public Device Record Key: dde03bcb-c794-4148-90a5-6dac95124783
Public Version Date: August 21, 2023
Public Version Number: 1
DI Record Publish Date: August 11, 2023