FDA.report

Medline

Primary DI
20888277699790
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
ENT911
Catalog number
ENT911
Device description
QCW, 14-16 FR, 39.5 CM, BLUE
Published
2021-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KNTTubes, gastrointestinal (and accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888277699790PackageGS110In Commercial Distribution
10888277699793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088827769979020888277699790
1088827769979310888277699793

GMDN Terms

TermDefinition
Enteral feeding/decompression tube clearing stemA non-sterile, sheath-covered device intended to be used to mechanically clear a clog in an in situ nasogastric, nasoenteral, gastrostomy and/or jejunostomy tube, used for feeding and/or decompression, to maintain luminal patency. It consists of a sheath and a stem clog disrupter (e.g., a wire or rod) designed to be magnetically coupled with a motorized actuator which facilitates the forward and backward movement of the disrupter inside the sheath. It typically has a collar to restrict the inserted length, and a diameter, appropriate for the installed feeding/decompression tube. This is a single-use device.

Device Sizes

TypeValueUnit
Length39.5Centimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Protect from freezing. Avoid excessive heat.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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