FDA.reportPublic FDA data

ProCure

Primary DI
10840330705100
Brand
ProCure
Company
Twin Med, LLC
Model
1007082
Catalog number
1007082
Device description
750cc Drainage bag with Y-Adapter and Hanger. Designed to ensure patients receive mist rather than liquid accumulated in the tubing. Includes hanger and bottom drainage port. Works with 22mm corrugated tubing 50/case.
Published
2024-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
30840330705104PackageGS150In Commercial Distribution
10840330705100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084033070510430840330705104
1084033070510010840330705100

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit condensate trap, single-useA non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator or respirator breathing circuit) to collect the condensate which accumulates typically during heated humidification. It includes a fluid collection container with input and output connections, and may have an automatic seal to prevent fluid leaks when removed from the circuit; it does not include a moisture filter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
612-819-1635sanderston@twinmed.com
804-776-2873xx@xx.xx

Regulatory Flags#

DUNS number
107071289
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840330706688ProCurePCHSWG15PCHSWG152026-05-04
10840330701911ProCurePC400PC4002026-05-27
10840330701928ProCurePC405PC4052026-05-27
10840330701935ProCurePC410PC4102026-05-27
10840330701942ProCurePC420PC4202026-05-27
10840330701959ProCurePC430PC4302026-05-27
10840330701966ProCurePC500PC5002026-05-27
10840330701973ProCurePC510PC5102026-05-27
10840330701980ProCurePC520PC5202026-05-27
10840330701997ProCurePC530PC5302026-05-27
10840330702253ProCurePCM500PCM5002026-05-27
10840330702260ProCurePCM510PCM5102026-05-27
10840330702277ProCurePCM520PCM5202026-05-27
10840330702284ProCurePCM530PCM5302026-05-27
10840330704868ProCurePCSS520PCSS5202026-05-27
10840330704875ProCurePCSS525PCSS5252026-05-27
10840330705162ProCurePC550PC5502026-05-27
10840330705179ProCurePC560PC5602026-05-27
10840330705186ProCurePC570PC5702026-05-27
10840330705193ProCurePC580PC5802026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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