FDA.reportPublic FDA data

AN11S - (11.11) - Andersen Nasogastric Tube, Pediatric, 10 Fr., with Stylet (Box

Primary DI
05060171440475
Brand
AN11S - (11.11) - Andersen Nasogastric Tube, Pediatric, 10 Fr., with Stylet (Box
Company
ANDERSEN PRODUCTS, INC.
Model
AN11.11
Device description
AN11S - (11.11) - Andersen Nasogastric Tube, Pediatric, 10 Fr., with Stylet (Box 10 Ct.)
Published
2017-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021493000ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18SAndersen Products, Inc.2002-08-30KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060171440475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060171440475050601714404755060171440475

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041867342
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060171440291Andersen Nasogastric Tube, 16 Fr. AN10.002017-01-24
05060171440307AN10S (10.11) - Andersen Nasogastric Tube, 16 Fr., with StyletAN10.11 2017-01-24
05060171440314AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr.AN11.002017-01-24
05060171440321AN11S - (11.11) - Andersen Nasogastric Tube, Pediatric, 10 Fr., with Stylet (IndAN11.112017-01-24
05060171440338AN11.50 - Andersen Nasogastric Tube, Pediatric, 10 Fr., Short (Individual)AN11.502017-01-24
05060171440345AN20 - Andersen Long Non-Mercury Weighted Sump Tube, 16 Fr. (Individual)AN20.002017-01-24
05060171440352AN22 - Andersen Miller-Abbott Type Intestinal Tube, 16 Fr., Pre-Weighted (IndiviAN22.002017-01-24
05060171440383AN10 - Andersen Nasogastric Tube, 16 Fr. (Box 10 Ct.)AN10.002017-01-24
05060171440390AN10 - Andersen Nasogastric Tube, 16 Fr. (Case 50 Ct.)AN10.002017-01-24
05060171440406AN10 - Andersen Nasogastric Tube, 16 Fr. (Overpack 250 Ct.)AN10.002017-01-24
05060171440413AN10S - (10.11) - Andersen Nasogastric Tube, 16 Fr., with Stylet (Box 10 Ct.)AN10.112017-01-24
05060171440420AN10S - (10.11) - Andersen Nasogastric Tube, 16 Fr., with Stylet (Case 50 Ct.)AN10.11 2017-01-24
05060171440437AN10S - (10.11) - Andersen Nasogastric Tube, 16 Fr., with Stylet (Overpack 250 CAN10.11 2017-01-24
05060171440444AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr. (Box 10 Ct.)AN11.002017-01-24
05060171440451AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr. (Case 50 Ct.)AN11.002017-01-24
05060171440468AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr. (Overpack 250 Ct.)AN11.002017-01-24
05060171440482AN11S - (11.11) - Andersen Nasogastric Tube, Pediatric, 10 Fr., with Stylet (CasAN11.112017-01-25
05060171440499AN11S - (11.11) - Andersen Nasogastric Tube, Pediatric, 10 Fr., with Stylet (OveAN11.112017-01-25
05060171440505AN11.50 - Andersen Nasogastric Tube, Pediatric, 10 Fr., Short (Box 10 Ct.)AN11.502017-01-25
05060171440512AN11.50 - Andersen Nasogastric Tube, Pediatric, 10 Fr., Short (Case 50 Ct.)AN11.502017-01-25

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