FDA.reportPublic FDA data

TubeClear

Primary DI
20850458007625
Brand
TubeClear
Company
ACTUATED MEDICAL, INC.
Model
TC-1018
Device description
Clearing Stem
Published
2017-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K163092000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163092000TubeClear Control Box and Clearing StemActuated Medical, Inc.2016-11-30KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850458007628PackageGS15In Commercial Distribution
20850458007625PackageGS110In Commercial Distribution
00850458007621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085045800762810850458007628
2085045800762520850458007625
00850458007621008504580076218504580076210850458007621

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791379030
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850458007089TubeClearG-10082017-10-02
00850458007096TubeClearG-10092017-10-02
00850458007102TubeClearG-10102017-10-02
00850458007119TubeClearG-10112017-10-02
00850458007126TubeClearG-10122016-10-27
00850458007140TubeClearG-10142016-10-27
00850458007423TubeClear NE-10422016-10-27
00850458007430TubeClearNE-10432016-10-27
00850458007454TubeClearNE-10452017-10-02
00850458007485TubeClearNE-10482016-10-27
00850458007508TubeClearNE-10502016-10-27
00850458007553TubeClearNE-10552016-10-27
00850458007607TubeClearTC-06082017-03-02
00850458007614TubeClearTC-08122017-03-02
00850458007621TubeClearTC-10182017-10-02
00850458007010TubeClearControl Box Model 101101-US2016-09-08
00850458007362TubeClearNE-10362016-10-27
00850458007195GripTract-GI Endoscopic Tissue ManipulatorGT-GS1002025-12-23
00850458007041GripTract-GI Endoscopic Tissue ManipulatorGT-1012025-01-16
00850458007003TubeClearGJ-1422GJ-14222021-01-01

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