FDA.reportPublic FDA data

East Coast Surgical Instruments

Primary DI
00850837007105
Brand
East Coast Surgical Instruments
Company
East Coast Surgical Inc.
Model
14-7102
Device description
"Filter For Insufflation Tubing W/ 6"" Pig-Tail"
Published
2017-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCXInsufflator, Automatic Carbon-Dioxide For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCXInsufflator, Automatic Carbon-Dioxide For EndoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850837007105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850837007105008508370071058508370071050850837007105

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of sterile flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source for insufflation during an endoscopic (including laparoscopic, arthroscopic) procedure. It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009464582
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850837007020East Coast Surgical Instruments14-82062017-08-24
00850837007037East Coast Surgical Instruments 14-8206V2017-08-24
00850837007044East Coast Surgical Instruments14-82142017-08-24
00850837007051East Coast Surgical Instruments14-28206VG-72017-08-24
00850837007068East Coast Surgical Instruments14-28300-VGCV-12017-08-24
00850837007075East Coast Surgical Instruments14-38205VG-12017-08-24
00850837007082East Coast Surgical Instruments14-38205VG-1L2017-08-24
00850837007099East Coast Surgical Instruments14-28206-VGFL2017-08-24
00850837007136East Coast Surgical Instruments14-81002017-08-24
00850837007143East Coast Surgical Instruments14-82002017-08-24
00850837007150East Coast Surgical Instruments14-82052017-08-24
00850837007167East Coast Surgical Instruments14-8300V2017-08-24
00850837007181East Coast Surgical Instruments14-8300CV2017-08-24
00850837007198East Coast Surgical Instruments14-83602017-08-24
00850887007174East Coast Surgical Instruments14-8300CRV2017-08-24
00850837007112East Coast Surgical Instruments14-71032017-08-24
00850837007129East Coast Surgical Instruments14-7103NS2017-08-24

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Primary DI, Brand, Company table
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10842942017312PRIMEDpriMED Medical Products IncFCX2025-07-14
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30815112021710DIN 477 High Pressure Hose for CO2Bracco Diagnostics Inc.FCX2025-06-30
10815112021570Protocol Administration Set With Flexi-Cuff Retention Tip Bracco Diagnostics Inc.FCX2025-05-16
30815112021574Protocol Administration Set With Flexi-Cuff Retention Tip Bracco Diagnostics Inc.FCX2025-05-16
04953170467219HIGH FLOW INSUFFLATION UNITOLYMPUS MEDICAL SYSTEMS CORP.FCX2025-02-27
00724995228897CO2MPACTUS EndoscopyFCX2024-11-25
04953170465963ENDOSCOPIC CO2 REGULATION UNITOLYMPUS MEDICAL SYSTEMS CORP.FCX2024-11-25
04055207007754NARichard Wolf GmbHFCX2024-08-19
04055207007761NARichard Wolf GmbHFCX2024-08-19
04055207007778NARichard Wolf GmbHFCX2024-08-19
04055207069875NARichard Wolf GmbHFCX2024-08-19
04055207069882NARichard Wolf GmbHFCX2024-08-19
04055207069899NARichard Wolf GmbHFCX2024-08-19
05391536920364Erbe ECO2 plusPALLIARE LIMITEDFCX2024-07-31
05391536920296EVA 5 InsufflatorPALLIARE LIMITEDFCX2024-05-16
06936534332246CO2 Source TubingZhejiang Chuangxiang Medical Technology Co., LTD.FCX2023-10-24
10815112021235Protocol Touch Colon InsufflatorBracco Diagnostics Inc.FCX2023-08-31
30815112021239Protocol Touch Colon InsufflatorBRACCO DIAGNOSTICS INCFCX2023-08-31
30815112021253DIN 477 High Pressure Hose for CO2Bracco Diagnostics Inc.FCX2023-08-31
30815112021291High Pressure Hose and YokeBracco Diagnostics Inc.FCX2023-08-31
10815112021266Protocol Accessory CartBracco Diagnostics Inc.FCX2023-07-07
30815112021260Protocol Accessory CartBRACCO DIAGNOSTICS INCFCX2023-07-07
10815112021242Protocol Touch Administration Set with Small Catheter and Retention CuffBracco Diagnostics Inc.FCX2023-06-29
10815112021280Protocol Administration Set with Small Catheter and Retention CuffBracco Diagnostics Inc.FCX2023-06-29
30815112021246Protocol Touch Administration Set with Small Catheter and Retention CuffBRACCO DIAGNOSTICS INCFCX2023-06-29
30815112021284Protocol Administration Set with Small Catheter and Retention CuffBRACCO DIAGNOSTICS INCFCX2023-06-29
04547410366037FUJIFILMFUJIFILM CORPORATIONFCX2022-10-07
04897106953790andorate® CO2 Extend Tubing with Luer ConnectorGA Health Company LimitedFCX2022-02-23