FDA.reportPublic FDA data

Pleural Drain Wet Seal System

Primary DI
00628725095370
Brand
Pleural Drain Wet Seal System
Company
CHS USA Inc.
Model
H03004
Catalog number
H03004
Device description
WET THORACIC DRAINAGE SYSTEM
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50628725095375PackageGS15In Commercial Distribution
00628725095370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872509537550628725095375
00628725095370006287250953706287250953700628725095370

GMDN Terms#

Term, Definition table
TermDefinition
Pleural/peritoneal drainage catheterization kit, non-medicatedA collection of non-powered devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions (e.g., haemothorax, empyema, ascites), other fluids, and/or air; some types are additionally intended for infusion of fluids/materials into the pleural/peritoneal space. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller), non-dedicated catheterization support devices (e.g., dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
118995594
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628725095363Pleural Drain Dry Seal System H03100H031002026-04-17
00628725095318Micro Minimuffs0403420403422026-01-07
50628725095313Micro Minimuffs0403420403422026-01-07
00628725050041Epidural Anesthesia KitCPT10ATCPT10AT2025-11-24
00628725050058Epidural Anesthesia KitCPT4CPT42025-11-24
00628725050065Epidural Anesthesia KitCPT4EXCPT4EX2025-11-24
50628725050046Epidural Anesthesia KitCPT10ATCPT10AT2025-11-24
50628725050053Epidural Anesthesia KitCPT4CPT42025-11-24
50628725050060Epidural Anesthesia KitCPT4EXCPT4EX2025-11-24
00628725050027Nerve Block TrayCPT114CPT1142025-11-21
00628725050003Nerve Block TrayCPT11CPT112025-11-20
00628725050010Nerve Block TrayCPT11SPCPT11SP2025-11-20
00628725050034Nerve Block TrayCPT116CPT1162025-11-20
50628725050008Nerve Block TrayCPT11CPT112025-11-20
50628725050015Nerve Block TrayCPT11SPCPT11SP2025-11-20
50628725050039Nerve Block TrayCPT116CPT1162025-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704937247PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937254PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937261PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937278PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937285PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937292PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937353PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
00628725095363Pleural Drain Dry Seal System CHS USA Inc.KDQ2026-04-17
40884389968100MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40884389968124MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40888277143020MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40888277143518MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40884389968070MEDLINEMEDLINE INDUSTRIES, INC.KDQ2025-11-28
14026704912190PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-17
14026704911780PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-04
14026704911902PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-07-02
14026704911872PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911889PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911896PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911919PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911926PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911933PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911940PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
10192253002652Thora-SealCardinal Health 200, LLCKDQ2025-02-19
10192253002645Thora-SealCardinal Health 200, LLCKDQ2025-02-18
10192253002669Thora-SealCardinal Health 200, LLCKDQ2025-02-18
10192253002676ArgyleCardinal Health 200, LLCKDQ2025-02-18
10073088165296BemisBEMIS MANUFACTURING COMPANYKDQ2025-02-07
10073088165302BEMISBEMIS MANUFACTURING COMPANYKDQ2025-02-07
40080196141822MEDLINEMEDLINE INDUSTRIES, INC.KDQ2024-12-19