AccessGUDID - DEVICE: SURFLO HYBRIA (36927675526367)

GUDID

Device Identifier (DI) Information

Brand Name: SURFLO HYBRIA
Version or Model: SH20252321AF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SH20252321AF
Company Name: Terumo Medical Products (Hangzhou) Co., Ltd.

Primary DI Number: 36927675526367
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 544830912 *Terms of Use

Device Description: SURFLO HYBRIA Closed 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?
64574	Peripheral intravenous cannula	A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.	Active	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 [?]
K252398	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: Avoid exposure to water, direct sunlight, extreme temperature, or high humidity during storage.Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 8.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1.1 MM
Catheter Gauge: 1 French
Length: 25 Millimeter
Device Size Text, specify: FLOWRATE 58ML/MIN

Device Record Status

Public Device Record Key: d3e52a49-fcb4-40da-bd0f-b141c452647b
Public Version Date: April 09, 2026
Public Version Number: 1
DI Record Publish Date: April 01, 2026