AccessGUDID - DEVICE: SURFLO™ (05413206055906)

GUDID

Device Identifier (DI) Information

Brand Name: SURFLO™
Version or Model: SV-S23WL35
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SV-S23WL35
Company Name: Terumo Europe NV

Primary DI Number: 05413206055906
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 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 [?]
K133867	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: Keep away from sunlight. Keep dry.
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
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: 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
Device Size Text, specify: Thin Wall

Device Record Status

Public Device Record Key: 304e78f7-70fa-4ee2-ba8b-1995bb241fab
Public Version Date: January 20, 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
55413206055901	5	35413206055907		In Commercial Distribution	Carton
35413206055907	100	05413206055906		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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