FDA.reportPublic FDA data

NA

Primary DI
40884521744050
Brand
NA
Company
Covidien LP
Model
7209822
Device description
Hysteroscopic Inflow Tube Set
Published
2018-08-31
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
HIGINSUFFLATOR, HYSTEROSCOPIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIGInsufflator, HysteroscopicObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521744056PackageGS15In Commercial Distribution
30884521744053PackageGS16In Commercial Distribution
40884521744050PackageGS18In Commercial Distribution
10884521744059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452174405620884521744056
3088452174405330884521744053
4088452174405040884521744050
1088452174405910884521744059

GMDN Terms#

Term, Definition table
TermDefinition
Straight/elbow breathing circuit connector, single-useA device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521091986NellcorSC-A-I2026-05-25
20884521841724Shiley50FXLTCP2026-03-17
20884521841687Shiley50FXLTCD2026-03-16
20884521841694Shiley60FXLTCD2026-03-16
20884521841700Shiley70FXLTCD2026-03-16
20884521841717Shiley80FXLTCD2026-03-16
20884521841731Shiley60FXLTCP2026-03-16
20884521841748Shiley70FXLTCP2026-03-16
20884521841755Shiley80FXLTCP2026-03-16
20884521841762Shiley50FXLTUD2026-03-16
20884521841779Shiley60FXLTUD2026-03-16
20884521841786Shiley70FXLTUD2026-03-16
20884521841793Shiley80FXLTUD2026-03-16
20884521841809Shiley50FXLTUP2026-03-16
20884521841816Shiley60FXLTUP2026-03-16
20884521841823Shiley70FXLTUP2026-03-16
20884521841830Shiley80FXLTUP2026-03-16
30884521841844Shiley50FXLTIN2026-03-16
20884521841854Shiley60FXLTIN2026-03-16
20884521841861Shiley70FXLTIN2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850033976342Symphion Operative Hysteroscopy System Prime Controller- RefurbishedMinerva Surgical, Inc.HIG2026-02-13
03700111401099RIGISTER CUPULE 20 mmLABORATOIRE CCDHIG2025-11-27
03700111401105RIGISTER CUPULE 25 mmLABORATOIRE CCDHIG2025-11-27
03700111401112RIGISTER CUPULE 30 mmLABORATOIRE CCDHIG2025-11-27
03700111401129RIGISTER CUPULE 35 mmLABORATOIRE CCDHIG2025-11-27
03700111401136SLIDING RIGISTER CUPULE 20 mmLABORATOIRE CCDHIG2025-11-27
03700111401143SLIDING RIGISTER CUPULE 25 mmLABORATOIRE CCDHIG2025-11-27
03700111401150SLIDING RIGISTER CUPULE 30 mmLABORATOIRE CCDHIG2025-11-27
03700111401167SLIDING RIGISTER CUPULE 35 mmLABORATOIRE CCDHIG2025-11-27
00850006759811Aveta Drape PumpMEDITRINA, INC.HIG2025-04-11
07613327626391ThermaClearSTRYKER CORPORATIONHIG2025-04-04
04048551377567NAKarl Storz GmbH & Co. KGHIG2025-03-27
00821925002630Gyrus ACMIGyrus ACMI, LLCHIG2024-12-09
15420045516144Fluent Pro Procedure KitHologic, Inc.HIG2024-10-15
15420045516212Fluent Pro Fluid Management SystemHologic, Inc.HIG2024-08-06
04056702012861GYN-PumpW.O.M. World of Medicine GmbHHIG2024-06-28
04056702012878Fluid Monitoring UnitW.O.M. World of Medicine GmbHHIG2024-06-28
00850006759477Aveta Smol Disposable Resecting Device, 2.9 mmMEDITRINA, INC.HIG2024-04-26
00850006759491Aveta Smol Disposable Resecting Device, 2.9 mmMEDITRINA, INC.HIG2024-04-26
00850006759620Aveta Smol Disposable Resecting Device, 2.9 mmMEDITRINA, INC.HIG2024-04-26
45420045505279Fluent Fluid Management SystemHologic, Inc.HIG2023-12-19
10850006759719Aveta Flex+ Disposable Resecting Device, 2.9 mmMEDITRINA, INC.HIG2023-12-01
10850006759726Aveta Max+ Disposable Resecting Device, 3.9 mmMEDITRINA, INC.HIG2023-12-01
10845854012963CONMEDConmed CorporationHIG2023-09-01
00850006759675Aveta Auto 5 Fr Disposable Resecting DeviceMEDITRINA, INC.HIG2022-08-18
30845854083936NAConmed CorporationHIG2022-06-06
00850006759606Aveta Wave+ Disposable Resecting Device, 3.9 mmMEDITRINA, INC.HIG2021-07-30
00850006759552Aveta Auto Disposable Resecting DeviceMEDITRINA, INC.HIG2021-02-11
00850006759330Aveta Flex Disposable Resecting Device, 2.9 mmMEDITRINA, INC.HIG2020-11-25
00850006759354Aveta Max Disposable Resecting Device, 3.9 mmMEDITRINA, INC.HIG2020-11-25