AccessGUDID - DEVICE: SURFLO (06927675506849)

GUDID

Brand Name: SURFLO
Version or Model: SV*S25BLSE
Catalog Number: SV*S25BLSE
Company Name: Terumo Medical Products (Hangzhou) Co., Ltd.

Primary DI Number: 06927675506849
Issuing Agency: GS1
Device Count: 1

Device Description: SURFLO Winged Infusion Set with Needle Protection

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Scalp vein intravenous administration set	A collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container into a patient's scalp vein. It typically includes tubing, connectors, chambers, clamps, and specialized needles to access scalp veins. The device is normally intended for use on paediatric patients, especially infants. This is a single-use device.

Product Code	Product Code Name
FPA	Set, administration, intravascular

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
Special Storage Condition, Specify: Do not store at extreme temperature and humidity.Fragile, handle with care. Keep away from heat. Keep dry .

Size Type Text
Device Size Text, specify: Type: Thin Wall (TW)
Length: 0.75 Inch
Total Volume: 0.19 Milliliter
Needle Gauge: 25 Gauge
Device Size Text, specify: Tubing Length:3.5inch

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 12, 2016
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
56927675506844	10	36927675506840		In Commercial Distribution	Carton
36927675506840	50	06927675506849		In Commercial Distribution	Shelfbox

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

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

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

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

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