FDA.reportPublic FDA data

NA

Primary DI
07613327055627
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
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
37613327055628PackageGS15Not in 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.

Contacts#

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

Regulatory Flags#

DUNS number
187502109
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327625172Steri-Shield04248010000424-801-0002025-02-21
07613327625257Steri-Shield04247212000424-721-2002025-02-21
07613327625288Steri-Shield04247412000424-741-2002025-02-21
07613327625295Steri-Shield04248211000424-821-1002025-02-21
07613327625332Steri-Shield04248212000424-821-2002025-02-21
07613327625349Steri-Shield04248312000424-831-2002025-02-21
07613327625363Steri-Shield04248512000424-851-2002025-02-21
07613327625370Steri-Shield04249210000424-921-0002025-02-21
07613327625387Steri-Shield04249410000424-941-0002025-02-21
07613327625394Steri-Shield04249510000424-951-0002025-02-21
07613327625400Steri-Shield04249310000424-931-0002025-02-21
07613327625417Steri-Shield04249412000424-941-2002025-02-21
07613327625424Steri-Shield04249311000424-931-1002025-02-21
07613327625431Steri-Shield04249211000424-921-1002025-02-21
07613327625448Steri-Shield04249312000424-931-2002025-02-21
07613327625455Steri-Shield04249512000424-951-2002025-02-21
07613327625462Steri-Shield04249212000424-921-2002025-02-21
07613327625479Steri-Shield04249511000424-951-1002025-02-21
07613327625486Steri-Shield04249411000424-941-1002025-02-21
07613327465655Neptune0703-046-0060703-046-0062019-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973031299207InsufflatorGuangdong Optomedic Technologies, Inc.HIF2026-04-22
04046955813360AESCULAPAesculap AGHIF2025-12-02
B3543000011ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000012ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000013ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000014ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000015ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000019ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000010ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
04046955813353AESCULAPAesculap AGHIF2025-05-18
04953170467219HIGH FLOW INSUFFLATION UNITOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-27
04055207007822NARichard Wolf GmbHHIF2024-08-19
04055207008393NARichard Wolf GmbHHIF2024-08-19
04055207058985NARichard Wolf GmbHHIF2024-08-19
05391536920937EVA15PALLIARE LIMITEDHIF2024-07-16
10845854045633AIRSEALConmed CorporationHIF2024-03-27
00886874120699NoneINTUITIVE SURGICAL, INC.HIF2024-03-25
B354OSLPCDG1Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG2Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG3Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG4Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG5Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG51Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG9Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG0Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
00850059707005AccuMedxAccumedx, LLCHIF2024-01-23
00850059707012AccuMedxAccumedx, LLCHIF2024-01-23
10845854045367CONMEDConmed CorporationHIF2023-12-04
09420012433978Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
10850082007186Filter AssemblyARMM INC.HIF2023-06-08