DEVICE: SURFLO (06927675506849)
Device Identifier (DI) Information
SURFLO
SV*S25BLSE
In Commercial Distribution
SV*S25BLSE
Terumo Medical Products (Hangzhou) Co., Ltd.
SV*S25BLSE
In Commercial Distribution
SV*S25BLSE
Terumo Medical Products (Hangzhou) Co., Ltd.
SURFLO Winged Infusion Set with Needle Protection
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FPA | Set, administration, intravascular |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]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 . |
Clinically Relevant Size
[?]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 |
Device Record Status
628f35f1-341b-4609-8798-adc339703119
March 29, 2018
2
September 12, 2016
March 29, 2018
2
September 12, 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 |
---|---|---|---|---|---|
56927675506844 | 10 | 36927675506840 | In Commercial Distribution | Carton | |
36927675506840 | 50 | 06927675506849 | 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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)283-7866
tmccustomer.admin@terumomedical.com
tmccustomer.admin@terumomedical.com