FDA.reportPublic FDA data

Maglinte

Primary DI
00827002054813
Brand
Maglinte
Company
COOK INCORPORATED
Model
G05481
Catalog number
MDEC-1400
Device description
Maglinte Decompression Sump/Enteroclysis Balloon Catheter
Published
2016-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEGTUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEGTube, Double Lumen For Intestinal Decompression And/Or IntubationGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002054813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002054813008270020548138270020548130827002054813

GMDN Terms#

Term, Definition table
TermDefinition
Nasogastric/orogastric tubeA sterile, hollow cylinder that can be introduced into the gastrointestinal (GI) tract both nasally and orally for feeding and/or aspiration. It is made of plastic or rubber and is available in a variety of designs and lengths. Some types are a simple rubber tube with a glass window; other types can be radiopaque to assist accurate placement, have multiple flow-through eyes, and dual connectors (e.g., one for suction and the other for irrigation/feeding). Other uses can be to decompress the stomach, withdraw specimens for diagnostic analysis, administer medications, and for irrigation of the stomach to treat upper gastrointestinal (UGI) bleeding. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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50192253006887Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253006900Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253012765Salem SumpCardinal Health 200, LLCFEG2026-01-16
20810141932542VIVIT SupplyVivit Supply LLCFEG2024-10-04
20884521740690Salem SumpCardinal Health, Inc.FEG2024-03-11
20884521740720Salem SumpCardinal Health, Inc.FEG2024-03-11
40884389965758MedlineMEDLINE INDUSTRIES, INC.FEG2024-02-16
50192253012789Salem SumpCardinal Health 200, LLCFEG2024-01-19
50192253012840Salem SumpCardinal Health 200, LLCFEG2024-01-19
50192253010099Salem SumpCardinal Health 200, LLCFEG2023-12-06
50192253010143Salem SumpCardinal Health 200, LLCFEG2023-12-06
50192253010181Salem SumpCardinal Health 200, LLCFEG2023-11-30
50192253010389Salem SumpCardinal Health 200, LLCFEG2023-11-30
50192253010624Salem SumpCardinal Health 200, LLCFEG2023-11-30
50192253009871KangarooCardinal Health 200, LLCFEG2023-11-16
10192253008203Salem SumpCardinal Health 200, LLCFEG2023-11-15
10192253008173Salem SumpCardinal Health 200, LLCFEG2023-11-14
10192253008197Salem SumpCardinal Health 200, LLCFEG2023-11-14
50192253010167Salem SumpCardinal Health 200, LLCFEG2023-11-06
50192253010129Salem SumpCardinal Health 200, LLCFEG2023-10-30
50192253010419Salem SumpCardinal Health 200, LLCFEG2023-10-30
50192253012826Salem SumpCardinal Health 200, LLCFEG2023-10-27
50192253010075Salem SumpCardinal Health 200, LLCFEG2023-10-25
50192253010211Salem SumpCardinal Health 200, LLCFEG2023-10-25