FDA.reportPublic FDA data

ProCure

Primary DI
10840330701805
Brand
ProCure
Company
Twin Med, LLC
Model
PCDB20
Catalog number
PCDB20
Device description
Drainage Bag, Urinary w/Anti Reflux Valve 2000ml, 20/cs
Published
2025-05-31
Public version status
Update
Distribution status
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
KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840330701809PackageGS120In Commercial Distribution
10840330701805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084033070180930840330701809
1084033070180510840330701805

GMDN Terms#

Term, Definition table
TermDefinition
Non-wearable adult urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
804-776-2873xx@xx.com

Regulatory Flags#

DUNS number
107071289
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253068603DoverCardinal Health 200, LLCKNX2026-01-16
10192253068719DoverCardinal Health 200, LLCKNX2026-01-16
10192253068726DoverCardinal Health 200, LLCKNX2026-01-16
10192253068733DoverCardinal Health 200, LLCKNX2026-01-16
10192253067989DoverCardinal Health 200, LLCKNX2026-01-15
10192253068016DoverCardinal Health 200, LLCKNX2026-01-15
10192253068214DoverCardinal Health 200, LLCKNX2026-01-15
10840330701799ProCureTwin Med, LLCKNX2025-05-31
10192253027792DoverCardinal Health 200, LLCKNX2025-04-01
10192253028232DoverCardinal Health 200, LLCKNX2025-04-01
10192253032161DoverCardinal Health 200, LLCKNX2025-04-01
20192253030058DoverCardinal Health 200, LLCKNX2025-04-01
10192253027945DoverCardinal Health 200, LLCKNX2025-03-20
10192253028461DoverCardinal Health 200, LLCKNX2024-12-20
10192253028522DoverCardinal Health 200, LLCKNX2024-12-20
10192253028539DoverCardinal Health 200, LLCKNX2024-12-20
10192253028546DoverCardinal Health 200, LLCKNX2024-12-20
10192253028560DoverCardinal Health 200, LLCKNX2024-12-20
10192253031126DoverCardinal Health 200, LLCKNX2024-12-20
10192253027938DoverCardinal Health 200, LLCKNX2024-11-04
10192253028287DoverCardinal Health 200, LLCKNX2024-11-04
10192253028492DoverCardinal Health 200, LLCKNX2024-11-04
10192253031447DoverCardinal Health 200, LLCKNX2024-11-04
10192253028195DoverCardinal Health 200, LLCKNX2024-10-14
10192253028201DoverCardinal Health 200, LLCKNX2024-10-14
10192253028263DoverCardinal Health 200, LLCKNX2024-10-14
10192253028386DoverCardinal Health 200, LLCKNX2024-10-14
10192253031379DoverCardinal Health 200, LLCKNX2024-10-14
10195327301927Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KNX2023-02-05
10884389941195MEDLINEMEDLINE INDUSTRIES, INC.KNX2022-11-30