FDA.reportPublic FDA data

ZZIREN® Orogastric Tube

Primary DI
00860013482152
Brand
ZZIREN® Orogastric Tube
Company
TOOLS FOR SURGERY, LLC
Model
ZZ-SGT-40
Catalog number
ZZ-SGT-40
Device description
ZZIREN® Orogastric Tube, 40 Fr, long hole pattern, single-use
Published
2025-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K242901000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242901000ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC2025-01-10KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013482152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013482152008600134821528600134821520860013482152

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 Gauge40French

Contacts#

Phone, Email table
PhoneEmail
631-444-4448customerservice@toolsforsurgery.com

Regulatory Flags#

DUNS number
841842441
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013482107ZZIREN® Orogastric TubeZZ-GBT-32ZZ-GBT-322025-11-21
00860013482114ZZIREN® Orogastric TubeZZ-SGT-32ZZ-SGT-322025-11-21
00860013482121ZZIREN® Orogastric TubeZZ-GBT-36ZZ-GBT-362025-11-21
00860013482138ZZIREN® Orogastric TubeZZ-SGT-36ZZ-SGT-362025-11-21
00860013482145ZZIREN® Orogastric TubeZZ-GBT-40ZZ-GBT-402025-11-21
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00860002701349Barbell Loop Ostomy DeviceBAR-3BAR-32023-07-17
00860002701356Barbell Loop Ostomy DeviceBAR-4BAR-42023-07-17
00860002701363SIREN SGTSGT-36SGT-362023-07-17
00861838000330WIKI Drain, 15 Fr, 3 cm, 1 DrainWIK-15-3-1WIK-15-3-12023-07-17
00861838000347WIKI Drain, 15 Fr, 3 cm, 6 DrainsWIK-15-3-6WIK-15-3-62023-07-17
00860002701318Colorectal Air Syringe-OP EXALT-30EXALT-30EX2019-12-17
00860002701332Colorectal Air Syringe-LP EXALT-50EXALT-50EX2019-12-17
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00861838000316Hemorrhage Occluder Pin with ApplicatorHOP-APHOP-AP2019-09-26
00861838000309Hemorrhage Occluder PinHOP-03HOP-032019-09-19

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