AccessGUDID - DEVICE: SURFLO™ (05413206054923)

GUDID

Device Identifier (DI) Information

Brand Name: SURFLO™
Version or Model: SV-S23FL35
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SV-S23FL35
Company Name: Terumo Europe NV

Primary DI Number: 05413206054923
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 370193559 *Terms of Use

Device Description: SURFLO™ WINGED INFUSION SET WITH FILTER AND 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":	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?
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 [?]
K133894	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
Storage Environment Temperature: between 2 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Needle Length: 19 Millimeter
Device Size Text, specify: Needle Outer Diameter: 0.6 Millimeter
Device Size Text, specify: Needle Length: 0.75 Inch
Needle Gauge: 23 Gauge
Pore Size: 20 Micrometer
Device Size Text, specify: Dead Space Volume: 0.20 Milliliter
Device Size Text, specify: Tube Length: 35 Centimeter
Device Size Text, specify: Tube Length: 13.8 Inch
Device Size Text, specify: Thin Wall

Device Record Status

Public Device Record Key: 5c4592a6-8ca0-4823-aebe-bc786c5013cd
Public Version Date: January 23, 2023
Public Version Number: 5
DI Record Publish Date: September 05, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
55413206054928	5	35413206054924		In Commercial Distribution	Carton
35413206054924	100	05413206054923		In Commercial Distribution	Shelfbox

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)283-7866
Email: tmccustomer.admin@terumomedical.com

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