SURFLO SV21BLSF

GUDID 56927675516317

SURFLO Winged Infusion Set

Terumo Medical Products (Hangzhou) Co., Ltd.

Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive
Primary Device ID56927675516317
NIH Device Record Keyc92013c2-2270-4783-9839-2a0eec85bbcc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURFLO
Version Model NumberSV21BLSF
Catalog NumberSV21BLSF
Company DUNS544830912
Company NameTerumo Medical Products (Hangzhou) Co., Ltd.
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com

Device Dimensions

Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch
Needle Gauge21 Gauge
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.2 Milliliter
Length0.75 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."
Special Storage Condition, SpecifyBetween 0 and 0 *" DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."

Device Identifiers

Device Issuing AgencyDevice ID
GS106927675516312 [Unit of Use]
GS136927675516313 [Primary]
GS156927675516317 [Package]
Contains: 36927675516313
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-21
Device Publish Date2023-08-11

On-Brand Devices [SURFLO]

56927675506844SURFLO Winged Infusion Set with Needle Protection
56927675516355SURFLO Winged Infusion Set
56927675516348SURFLO Winged Infusion Set
56927675516331SURFLO Winged Infusion Set
56927675516324SURFLO Winged Infusion Set
56927675516317SURFLO Winged Infusion Set
56927675516300SURFLO Winged Infusion Set
56927675515488SURFLO Winged Infusion Set
56927675515471SURFLO Winged Infusion Set
56927675515464SURFLO Winged Infusion Set
56927675515457SURFLO Winged Infusion Set
56927675515440SURFLO Winged Infusion Set
56927675515433SURFLO Winged Infusion Set
56927675515389SURFLO Winged Infusion Set
56927675515372SURFLO Winged Infusion Set
56927675515426SURFLO Winged Infusion Set
56927675515419SURFLO Winged Infusion Set
56927675515402SURFLO Winged Infusion Set
56927675515396SURFLO Winged Infusion Set

Trademark Results [SURFLO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURFLO
SURFLO
98020905 not registered Live/Pending
ChampionX USA Inc.
2023-05-31
SURFLO
SURFLO
79256772 5911338 Live/Registered
surflo Co., Ltd.
2019-03-05
SURFLO
SURFLO
74019926 not registered Dead/Abandoned
Continental Industries, Inc.
1990-01-17
SURFLO
SURFLO
73141306 1154325 Dead/Cancelled
N L INDUSTRIES, INC.
1977-09-15
SURFLO
SURFLO
73034902 1028554 Live/Registered
KABUSHIKI KAISHA JINTAN TERUMO
1974-10-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.