FDA.reportPublic FDA data

Insuflow Port

Primary DI
00852588007182
Brand
Insuflow Port
Company
LEXION MEDICAL, LLC
Model
4100-10
Catalog number
4100-10
Device description
10mm x 100mm Insuflow Port
Published
2020-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
HIFInsufflator, Laparoscopic
OSVInsufflator, Endoscopic Vessel Harvesting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HIFInsufflator, LaparoscopicObstetrics/Gynecology2
OSVInsufflator, Endoscopic Vessel HarvestingObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170799000AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC2017-11-14HIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852588007182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852588007182008525880071828525880071820852588007182

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
848693730
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852588007229AP50/30 410041002020-11-02
00852588007014Insuflow6198NS6198NS2017-02-15
00852588007021INSUFLOWPP1000NSPP1000NS2017-02-15
00852588007069VERYCLEAR151515152017-02-15
00852588007083INSUFLOW SYNERGY PORT199119912017-02-15
00852588007090INSUFLOW SYNERGY XL PORT 1991-81991-82017-02-15
00852588007106INSUFLOW SYNERGY XL PORT1991-101991-102017-02-15
00852588007113INSUFLOW SYNERGY XL PORT1991-121991-122017-02-15
00852588007120INSUFLOW SYNERGY XL PORT1991-8B1991-8B2017-02-15
00852588007137iNSUFLOW SYNERGY XL PORT1991-10B1991-10B2017-02-15
00852588007144INSUFLOW SYNERGY XL PORT1991-12B1991-12B2017-02-15
00852588007243Standard filtered tube set4100-SHT4100-SHT2020-11-05
00852588007151Insuflow Port4100-54100-52020-11-05
00852588007168Insuflow Port4100-84100-82020-11-05
00852588007175Insuflow Port4100-8B4100-8B2020-11-05
00852588007199Insuflow Port4100-10B4100-10B2020-11-05
00852588007205Insuflow Port4100-124100-122020-11-05
00852588007212Insuflow Port4100-12B4100-12B2020-11-05
00852588007236Insuflow Port4100-5B4100-5B2020-11-05
00852588007038INSUFLOW6198M6198M2017-02-15

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Primary DI, Brand, Company table
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