FDA.reportPublic FDA data

OCEAN

Primary DI
20650862100345
Brand
OCEAN
Company
ATRIUM MEDICAL CORPORATION
Model
2002-040
Device description
DRAIN, SINGLE, PEDI CONNECTOR
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043582000OCEAN CHEST DRAINAtrium Medical Corp.2005-01-21KDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20650862100345PackageGS16In Commercial Distribution
00650862100341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065086210034520650862100345
00650862100341006508621003416508621003410650862100341

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic suction collection containerA device intended to be connected between a thoracic drainage catheter (not included) and a suction wall outlet, to collect fluids (e.g., blood), secretions and/or air during controlled aspiration of the pleural cavity and/or mediastinum. The device typically incorporates three graduated chambers, designed for fluid collection, water seal, and suction control, and a suction regulator, air leak indicator, and connection tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051798999
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00650862122916iCast covered stent system, 12mm x 29mm x 80cmGBX12291A2026-02-18
00650862122923iCast covered stent system, 12mm x 29mm x 120cmGBX12292A2026-02-18
00650862124118iCast covered stent system, 12mm x 41mm x 80cmGBX12411A2026-02-18
00650862124125iCast covered stent system, 12mm x 41mm x 120cmGBX12412A2026-02-18
00650862126112iCast covered stent system, 12mm x 61mm x 80cmGBX12611A2026-02-18
00650862126129iCast covered stent system, 12mm x 61mm x 120cmGBX12612A2026-02-18
00650862425321iCast covered stent system, 5mm x 32mm x 120cm425322026-02-18
00650862426328iCast covered stent system, 6mm x 32mm x 120cm 426322026-02-18
00650862427325iCast covered stent system, 7mm x 32mm x 120cm427322026-02-18
00650862428322iCast covered stent system, 8mm x 32mm x 120cm428322026-02-18
00650862429329iCast covered stent system, 9mm x 32mm x 120cm429322026-02-18
00650862480597iCast covered stent system, 10mm x 59mm x 80cm480592026-02-18
00650862485325iCast covered stent system, 5mm x 32mm x 80cm485322026-02-18
00650862486322iCast covered stent system, 6mm x 32mm x 80cm 486322026-02-18
00650862487329iCast covered stent system, 7mm x 32mm x 80cm 487322026-02-18
00650862488326iCast covered stent system, 8mm x 32mm x 80cm 488322026-02-18
00650862489323iCast covered stent system, 9mm x 32mm x 80cm489322026-02-18
00650862720594iCast covered stent system, 10mm x 59mm x 120cm720592026-02-18
00650862420388iCast Covered Stent System, 10mmX38mmX120cm42038420382023-06-09
00650862425161iCast Covered Stent System, 5mmX16mmX120cm42516425162023-06-09

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
00628725095370Pleural Drain Wet 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