FDA.reportPublic FDA data

Salem Sump

Primary DI
10884521004658
Brand
Salem Sump
Company
Cardinal Health, Inc.
Model
8888266106
Catalog number
8888266106
Device description
Dual Lumen Stomach Tube,Anti-Reflux Valve
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
K880850000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K880850000KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVEKmb Medical Products Co.1988-05-26FEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521004658PackageGS150In Commercial Distribution
20884521004655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452100465810884521004658
2088452100465520884521004655

GMDN Terms#

Term, Definition table
TermDefinition
Nasogastric decompression tubeA sterile, thin, flexible, hollow, single- or double-lumen cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily to reduce the pressure within the gastrointestinal tract, typically aided by connection to an intermittent suction system, that may follow presurgical or postsurgical intestinal occlusion. It may also be used for the delivery of fluids (for irrigation, enteral feeding, and medication administration) typically for the period that gastric decompression is required. This device may be referred to as a nasogastric sump tube or a gastrointestinal decompression tube. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Length36Inch

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
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24
10884521154100Devon31146895311468952016-09-24
10192253059984Dover7014MF7014MF2022-06-07
10884521013230Monoject888122524188812252412016-09-24
10884521013254Monoject888122524588812252452016-09-24
10884521024854Kendall923892382018-06-27
10884521004498Dover1455001455002016-09-24
10884521014091Monoject888150164088815016402016-09-24
10884521163041Magellan888185005888818500582016-09-24
10884527021932Uni-PatchEP84580EP845802016-09-24
20884521012216Monoject888153578888815357882016-09-24
20884521012254Monoject888156018288815601822016-09-24
20884521014159Monoject888151613588815161352016-10-13
10884521518889Kangaroo888472109688847210962016-09-24

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