FDA.reportPublic FDA data

Cohen

Primary DI
00827002299535
Brand
Cohen
Company
COOK INCORPORATED
Model
G29953
Catalog number
C-AEBTS-9.0-65-SPH
Device description
Cohen Endobronchial Blocker Set
Published
2015-10-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBITUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002299535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002299535008270022995358270022995350827002299535

GMDN Terms#

Term, Definition table
TermDefinition
Endobronchial tubeA hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. 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
false
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
Primary DIBrandCompanyProduct codePublished
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34026704941217SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
34026704941224HUDSON RCITELEFLEX INCORPORATEDCBI2025-12-11
24026704941234SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
24026704941241SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
08800115141801Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141818Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141825Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141832Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141849Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141856Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141863Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141870Human-broncho endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141924ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141931ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141948ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141955ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141962ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141979ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141986ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
08800115141993ANKOR endobronchial tubeINSUNG MEDICAL Co., Ltd..CBI2025-04-29
34026704743347RUSCHTELEFLEX INCORPORATEDCBI2024-05-20
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14544050123836UNIVENT TUBE (TCB TYPE)FUJI SYSTEMS CORPORATIONCBI2024-01-31