FDA.reportPublic FDA data

NA

Primary DI
37613327055628
Brand
NA
Company
STRYKER CORPORATION
Model
0620030407
Catalog number
620-030-407
Device description
[High Flow Heated Insufflator Tubing, Do not use if package is damaged]
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIFINSUFFLATOR, LAPAROSCOPIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327055628PackageGS15In Commercial Distribution
07613327055627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332705562837613327055628
07613327055627076133270556277613327055627

GMDN Terms#

Term, Definition table
TermDefinition
Insufflation gas conditioning tubing setA collection of sterile and non-sterile devices intended to be used with an insufflation gas conditioning system and/or a laparoscopic gas distention system, or other gas source, to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying it before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is available in various configurations but typically includes a connection tube for connection to the gas source, an electrically-heated tube for transport of the conditioned gas to the operative site, a humidification chamber, a gas filter, and connectors. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972304751404InflaCureSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HIF2026-05-22
16972304751555InflaCureSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HIF2026-05-22
10851885004587AIRSEALConmed CorporationHIF2026-03-21
00860012249954VereSeeFreyja Healthcare, LLCHIF2025-06-18
00860012249916VereSeeFreyja Healthcare, LLCHIF2025-06-16
G465100300AirSurgN InsufflatorSmartsurgn Inc.HIF2025-04-22
04953170467226INSUFFLATION TUBEOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-26
04953170467233SUCTION TUBEOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-26
05391536920142EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920159EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920913EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920944EVA15PALLIARE LIMITEDHIF2024-07-16
06937845500607GTKGuangzhou T.K Medical Instrument Co.,Ltd.HIF2024-05-23
06937845500614GTKGuangzhou T.K Medical Instrument Co.,Ltd.HIF2024-05-23
20845854045630AIRSEALConmed CorporationHIF2024-03-27
06973031299573Insufflation tubeGuangdong Optomedic Technologies, Inc.HIF2024-03-26
06973031299870Insufflation tubeGuangdong Optomedic Technologies, Inc.HIF2024-03-26
06973031299887InsufflatorGuangdong Optomedic Technologies, Inc.HIF2024-03-26
10886874120696NoneINTUITIVE SURGICAL, INC.HIF2024-03-25
06971381251357InsufflatorSCIVITA MEDICAL TECHNOLOGY CO., LTD.HIF2024-02-28
06971381251364InsufflatorSCIVITA MEDICAL TECHNOLOGY CO., LTD.HIF2024-02-28
10845854045350CONMEDConmed CorporationHIF2023-12-04
10845854045398CONMEDConmed CorporationHIF2023-12-04
00810143450545MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpHIF2023-07-31
00810143450750MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpHIF2023-07-31
09420012433060Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
09420012433985Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
00850082007189Filter AssemblyARMM INC.HIF2023-06-08
00850082007196Insufflator Filter AssemblyARMM INC.HIF2023-06-08
00850082007837Insufflator Filter AssemblyARMM INC.HIF2023-06-08