AccessGUDID - DEVICE: SURFLO MIDELA (36927675520747)

GUDID

Device Identifier (DI) Information

Brand Name: SURFLO MIDELA
Version or Model: MCS2010D01F
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCS2010D01F
Company Name: Terumo Medical Products (Hangzhou) Co., Ltd.

Primary DI Number: 36927675520747
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 544830912 *Terms of Use

Device Description: SURFLO MIDELA Midline Catheter Basic Kit

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:	Yes
Combination Product:	Yes
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?
32151	Peripheral vascular intervention infusion catheter	A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. 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
PND	Midline Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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.Fragile, handle with care. Keep away from sunlight. Keep dry .Stacking limit by 5.

Clinically Relevant Size

[?]

Size Type Text
Length: 100 Millimeter
Catheter Gauge: 1.0 French
Device Size Text, specify: 1.1 MM

Device Record Status

Public Device Record Key: 15d8673f-dce6-4f68-bbb1-3dd507b8b22c
Public Version Date: April 09, 2026
Public Version Number: 1
DI Record Publish Date: April 01, 2026