FDA.reportPublic FDA data

Cook

Primary DI
00827002102118
Brand
Cook
Company
COOK INCORPORATED
Model
G10211
Catalog number
PCS-830-LOCK-CARD
Device description
Lock Pericardiocentesis Set
Published
2020-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBXCATHETER, IRRIGATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002102118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002102118008270021021188270021021180827002102118

GMDN Terms#

Term, Definition table
TermDefinition
Pericardiocentesis catheterA flexible tube designed for the drainage of effusion from the pericardial sac (the pericardium). It typically consists of a thin walled, flexible, plastic [e.g., polyethylene (PE)] tube with a J-shaped distal tip perforated with multiple holes in both its convex and concave sides. It is introduced percutaneously into the pericardium, anchored in place, and connected to a water-seal drainage system. It can be left in situ for some days or weeks during the treatment of cardiac tamponade and can be used for the irrigation/instillation of drugs (e.g., antibiotics, cytotoxic agents) into the pericardium. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

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Primary DI, Brand, Company table
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34026704933373PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-08
34026704933380PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-02
24026704933406PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-02
10884450581008ReSolve®Merit Medical Systems, Inc.GBX2025-05-23
10661392032009LSL HEALTHCARELSL Industries, LLCGBX2025-05-16
10884450779900ReSolve®Merit Medical Systems, Inc.GBX2025-05-13
00840456205891JMUJMU DENTAL, INCGBX2025-05-02
24026704933345PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933352PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933413PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933468PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933472PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933489PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
24026704933499PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933502PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933519PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933526PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933311PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
34026704933328PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933338PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
34026704933366PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933390PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933420PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933437PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933444PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
34026704933458PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
10884450719937ReSolve Mini™Merit Medical Systems, Inc.GBX2025-03-15