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
10840330702208ProCurePC650CBPC650CB2026-06-01
10840330702215ProCurePC660CBPC660CB2026-06-01
10840330702222ProCurePC670CBPC670CB2026-06-01
10840330702239ProCurePC680CBPC680CB2026-06-01
10840330702246ProCurePC690CBPC690CB2026-06-01
10840330706756ProCurePC600CB-APC600CB-A2026-06-01
10840330706763ProCurePC610CB-APC610CB-A2026-06-01
10840330706770ProCurePC620CB-APC620CB-A2026-06-01
10840330706787ProCurePC630CB-APC630CB-A2026-06-01
10840330706794ProCurePC640CB-APC640CB-A2026-06-01
10840330702000ProCurePC600BLKPC600BLK2026-05-29
10840330702024ProCurePC600CBPC600CB2026-05-29
10840330702048ProCurePC610BLKPC610BLK2026-05-29
10840330702062ProCurePC610CBPC610CB2026-05-29
10840330702086ProCurePC620BLKPC620BLK2026-05-29
10840330702109ProCurePC620CBPC620CB2026-05-29
10840330702123ProCurePC630BLKPC630BLK2026-05-29
10840330702147ProCurePC630CBPC630CB2026-05-29
10840330702161ProCurePC640BLKPC640BLK2026-05-29
10840330702185ProCurePC640CBPC640CB2026-05-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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30889483570771AirLife™Sunmed Group Holdings, LLCBYH2025-02-20
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30889483585751AirLife™Sunmed Group Holdings, LLCBYH2025-02-12