FDA.reportPublic FDA data

Salem Sump

Primary DI
10884521004542
Brand
Salem Sump
Company
Cardinal Health, Inc.
Model
7771610
Catalog number
7771610
Device description
Dual Lumen Stomach Tube,Multi-functional Port
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040388000NEXT GENERATION SALEM SUMPKendall2004-05-17FEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521004542PackageGS110In Commercial Distribution
20884521004549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452100454210884521004542
2088452100454920884521004549

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French
Length48Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
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
10884521000308Dover20042004-2016-09-24
10884521000681Dover202020202016-09-24
10884521001039Dover20142014-2016-09-24
10884521001053Dover20182018-2016-09-24
10884521001084Dover625662562016-09-24
10884521009455Dover34203420-2016-09-24
10884521009585Dover3450LF3450LF2016-09-24
10884521082403Curity260026002018-06-29
10884521084216Kerlix26719267192018-06-29
10884521158863Kendall2419CD2419CD2018-06-28
10884527020782Curity260126012018-06-29
10884521174917Devon31141206311412062016-09-24
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253012460Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253012484Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253012507Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253012521Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253012989Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253013009Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253060928Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253012468Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253012482Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253012529Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253013007Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253060926Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253006872Salem SumpCardinal Health 200, LLCFEG2026-01-16
10192253006889Salem SumpCardinal Health 200, LLCFEG2026-01-16
10192253006902Salem SumpCardinal Health 200, LLCFEG2026-01-16
10192253012767Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253006870Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253006887Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253006900Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253012765Salem SumpCardinal Health 200, LLCFEG2026-01-16
10810141932545VIVIT SupplyVivit Supply LLCFEG2024-10-04
20810141932542VIVIT SupplyVivit Supply LLCFEG2024-10-04
10884521740693Salem SumpCardinal Health, Inc.FEG2024-03-11
10884521740709Salem SumpCardinal Health, Inc.FEG2024-03-11
10884521740716Salem SumpCardinal Health, Inc.FEG2024-03-11
10884521740723Salem SumpCardinal Health, Inc.FEG2024-03-11
10884521740730Salem SumpCardinal Health, Inc.FEG2024-03-11
20884521740690Salem SumpCardinal Health, Inc.FEG2024-03-11
20884521740720Salem SumpCardinal Health, Inc.FEG2024-03-11
10884389965757MedlineMEDLINE INDUSTRIES, INC.FEG2024-02-16