FDA.reportPublic FDA data

Surestream

Primary DI
10884521552272
Brand
Surestream
Company
ORIDION MEDICAL 1987 LTD.
Model
011719
Device description
SURESTREAM
Published
2018-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYHDRAIN, TEE (WATER TRAP)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYHDrain, Tee (Water Trap)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521552279PackageGS110In Commercial Distribution
30884521552276PackageGS125In Commercial Distribution
10884521552272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452155227920884521552279
3088452155227630884521552276
1088452155227210884521552272

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
600111512
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884521551906Microstream015179_RMS12016-09-30
20884521551999Microstream0111082016-09-30
20884521761787Microstream AdvanceMVINH2020-07-04
20884521761794Microstream AdvanceMVINHL2020-07-04
20884521761800Microstream AdvanceMVINOH2020-07-23
20884521761824Microstream AdvanceMVANOH2020-07-23
20884521771731Microstream AdvanceMVIN2020-08-05
10884521552104Microstream012521_RMS12018-01-11
10884521551954Microstream015776_RMS12018-01-11
20884521761565Microstream AdvanceMVA2020-01-09
20884521761572Microstream AdvanceMVAL2020-01-09
20884521761589Microstream AdvanceMVAL100U2020-01-30
20884521761596Microstream AdvanceMVAO2020-02-28
20884521761602Microstream AdvanceMVAO100U2020-02-28
20884521761619Microstream AdvanceMVAOL2020-01-09
20884521761626Microstream AdvanceMVAOL100U2020-01-30
20884521761640Microstream AdvanceMVPO2020-01-09
20884521761657Microstream AdvanceMVPOL2020-01-09
20884521761664Microstream AdvanceMVAOH2020-07-04
20884521761671Microstream AdvanceMVAOH100U2020-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04710810084157N/AGALEMED CORPORATIONBYH2026-03-04
04710810119491N/AGALEMED CORPORATIONBYH2026-03-04
04710810119507N/AGALEMED CORPORATIONBYH2026-03-04
04710810119545N/AGALEMED CORPORATIONBYH2026-03-04
04710810119552N/AGALEMED CORPORATIONBYH2026-03-04
04710810119569N/AGALEMED CORPORATIONBYH2026-03-04
04710810119576N/AGALEMED CORPORATIONBYH2026-03-04
24710810084151N/AGALEMED CORPORATIONBYH2026-03-04
44710810119499N/AGALEMED CORPORATIONBYH2026-03-04
44710810119505N/AGALEMED CORPORATIONBYH2026-03-04
44710810119543N/AGALEMED CORPORATIONBYH2026-03-04
44710810119550N/AGALEMED CORPORATIONBYH2026-03-04
44710810119567N/AGALEMED CORPORATIONBYH2026-03-04
44710810119574N/AGALEMED CORPORATIONBYH2026-03-04
10197344011018HUDSON RCIMEDLINE INDUSTRIES, INC.BYH2025-08-18
20197344011015HUDSON RCIMEDLINE INDUSTRIES, INC.BYH2025-08-18
10889483571910AirLife™AIRLIFEBYH2025-03-28
30889483571914AirLife™Sunmed Group Holdings, LLCBYH2025-03-28
10889483570937AirLife™AIRLIFEBYH2025-03-18
10889483570951AirLife™AIRLIFEBYH2025-03-18
30889483570931AirLife™Sunmed Group Holdings, LLCBYH2025-03-18
30889483570955AirLife™Sunmed Group Holdings, LLCBYH2025-03-18
10889483570777AirLife™AIRLIFEBYH2025-02-20
10889483570784AirLife™AIRLIFEBYH2025-02-20
10889483570944AirLife™AIRLIFEBYH2025-02-20
30889483570771AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
30889483570788AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
30889483570948AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
10889483585757AirLife™AIRLIFEBYH2025-02-12
30889483585751AirLife™Sunmed Group Holdings, LLCBYH2025-02-12