FDA.reportPublic FDA data

Hollister

Primary DI
10610075167767
Brand
Hollister
Company
HOLLISTER INCORPORATED
Model
9786
Device description
Feeding tube attachment device- Accommodates 5Fr to 18Fr tubes
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
K893888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893888000HOLLISTER FEEDING TUBE ATTACHMENT DEVICEHollister, Inc.1989-10-17KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610075167767PackageGS124In Commercial Distribution
00610075167760PrimaryGS10
00610075083640Unit of UseGS10
00610075097869Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007516776710610075167767
00610075167760006100751677606100751677600610075167760
00610075083640006100750836406100750836400610075083640
00610075097869006100750978696100750978690610075097869

GMDN Terms#

Term, Definition table
TermDefinition
Nasogastric tube holder, noninvasiveA small, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient. It is typically designed as an adhesive plaster with wings that are attached to the face (e.g., across the bridge of the nose, on the cheeks). It may have a lock-ring or non-adhesive tabs that is/are attached to the nasogastric tube (placed through a nostril and via the oesophagus) to hold it safely and comfortably in place. The lock-ring or tabs can be removed without scissors for easy removal of the tube. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-4060cs@hollister.com

Regulatory Flags#

DUNS number
005527098
Device count
20
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610075098217Hollister982198212022-12-01
00610075098224Hollister982298222022-12-01
00610075098231Hollister982398232022-12-01
00610075098804Hollister988098802022-12-01
00610075040070InstaFlo330162016-09-21
00610075179626ActiFlo320042016-09-21
00610075179633ActiFlo320052016-09-21
00610075179640ActiFlo320062016-09-21
00610075179657ActiFlo320072016-09-21
10610075180292Advance Plus Pocket93104IC93104IC2016-09-21
10610075180308Advance Plus Pocket93124IC93124IC2016-09-21
10610075180315Advance Plus Pocket93144IC93144IC2016-09-21
10610075180322Advance Plus Pocket93164IC93164IC2016-09-21
00610075077243Hollister772477242022-12-01
00610075077281Hollister772877282022-12-01
00610075095667VaPro Plus Pocket Kit79089K79089K2024-07-15
00610075095674VaPro Plus Pocket Kit79109K79109K2024-07-15
00610075095681VaPro Plus Pocket Kit79129K79129K2024-07-15
00610075095698VaPro Plus Pocket Kit79149K79149K2024-07-15
00610075095704VaPro Plus Pocket Kit79169K79169K2024-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842071147259MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071147266MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00350770997780MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTWAvanos Medical, Inc.KNT2026-10-20
00350770997797MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTWAvanos Medical, Inc.KNT2026-10-20
00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00842071146337MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146344MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146375MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146382MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146795MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146801MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147136MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147143MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
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00842071147167MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20