FDA.reportPublic FDA data

ESI

Primary DI
B3961600020
Brand
ESI
Company
FTT MEDICAL, INC.
Model
16-0002
Device description
SPECIAL SUCTION TUBE
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3961600020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, illuminating, reusableAn atraumatic, invasive, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or clear an airway obstruction, whilst providing illumination of the site. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic, nor an intravascular device; it is not designed for surgical irrigation. It has a built-in light or fibreoptic bundle used to illuminate the operative site. Often referred to a as suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or tubing. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
002212793
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B39615001700ESI15-001702016-09-16
B3961501500ESI15-01502016-09-16
B3961501520ESI15-01522016-09-16
B3961501540ESI15-01542016-09-16
B3961501580ESI15-01582016-09-16
B3961501590ESI15-01592016-09-16
B3961501710ESI15-01712016-09-16
B3961501720ESI15-01722016-09-16
B396150172O0ESI15-0172-O2016-09-16
B3961501730ESI15-01732016-09-16
B3961501740ESI15-01742016-09-16
B3961501750ESI15-01752016-09-16
B3961501800ESI15-01802016-09-16
B3961501820ESI15-01822016-09-16
B3961501840ESI15-01842016-09-16
B3961501900ESI15-01902016-09-16
B3961501920ESI15-01922016-09-16
B3961501940ESI15-01942016-09-16
B3961501980ESI15-01982016-09-16
B3961502700ESI15-02702016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253038927ArgyleCardinal Health 200, LLCJOL2026-05-07
10080196994137MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-27
10080196035458MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196995561MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196035434MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
10080196995554MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
10192253039665CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
07613327680720Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
10197344153671MEDLINEMEDLINE INDUSTRIES, INC.JOL2025-05-21
10192253041866ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253041873ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253041880ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253038941ArgyleCardinal Health 200, LLCJOL2025-02-28
10192253038958ArgyleCardinal Health 200, LLCJOL2025-02-28
10192253039672ArgyleCardinal Health 200, LLCJOL2024-12-04
10192253003628ArgyleCardinal Health 200, LLCJOL2024-10-09
10192253002928ArgyleCardinal Health 200, LLCJOL2024-09-27
10192253002935ArgyleCardinal Health 200, LLCJOL2024-09-27
10192253002942ArgyleCardinal Health 200, LLCJOL2024-09-27
10192253057294ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057300ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057317ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057324ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057348ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057355ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057362ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057379ArgyleCardinal Health 200, LLCJOL2024-08-02