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
00628725050416Epidural Anesthesia Kit Clint PharmaceuticalsCPT7CPT72026-07-21
00628725050287Nerve Block Tray Clint PharmaceuticalsCPT22Q45CPT22Q452026-07-20
00628725050294Nerve Block Tray Clint PharmaceuticalsCPT25Q35CPT25Q352026-07-20
00628725050300Epidural Anesthesia Kit Clint PharmaceuticalsCPT3CPT32026-07-20
00628725050331Epidural Anesthesia Kit Clint PharmaceuticalsCPT5CPT52026-07-20
00628725050362Epidural Anesthesia Kit Clint PharmaceuticalsCPT5SPCPT5SP2026-07-20
00628725050379Epidural Anesthesia Kit Clint PharmaceuticalsCPT6CPT62026-07-20
00628725050409Epidural Anesthesia Kit Clint PharmaceuticalsCPT6SPCPT6SP2026-07-20
00628725050423Epidural Anesthesia Kit Clint PharmaceuticalsCPT7SPCPT7SP2026-07-20
00628725050188Nerve Block TrayCPT110CPT1102026-07-17
00628725050195Nerve Block TrayCPT11CHCPT11CH2026-07-17
00628725050201Nerve Block TrayCPT11KCCPT11KC2026-07-17
00628725050232Epidural Anesthesia Kit Clint PharmaceuticalsCPT17SPGCPT17SPG2026-07-17
00628725050249Epidural Anesthesia Kit Clint PharmaceuticalsCPT18LCPT18L2026-07-17
00628725050256Epidural Anesthesia Kit Clint PharmaceuticalsCPT20LCPT20L2026-07-17
00628725050270Epidural Anesthesia Kit Clint PharmaceuticalsCPT20SCPT20S2026-07-17
00628725050324Epidural Anesthesia KitCPT4SPCPT4SP2026-07-17
00628725050003Nerve Block TrayCPT11CPT112025-11-20
00628725050058Epidural Anesthesia KitCPT4CPT42025-11-24
00628725050010Nerve Block TrayCPT11SPCPT11SP2025-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874957476Create BiotechCREATE BIOTECH CO., LTD.KDQ2026-07-21
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00850079671102NavägeRhinosystems, Inc.KDQ2026-06-10
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
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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
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