FDA.reportPublic FDA data

NeoDevices, Inc.

Primary DI
10816340027754
Brand
NeoDevices, Inc.
Company
NEODEVICES INC
Model
ND36EOY
Device description
36" Bifurcated Orange Stripe Extension Set with non-IV Stepped Adapter and enteral only connector with 2" orange stripe tube with enteral only connector
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816340027754PackageGS150In Commercial Distribution
10816340022063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081634002775410816340027754
1081634002206310816340022063

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy tube Y-piece connectorA connecting device shaped in the form of a "Y" intended for connection to the proximal end of a gastrostomy tube to enable administration of nutrient liquids and/or medication through the gastrostomy tube. It has two resealable ports intended for flushing the line and/or administering medications without the need for tube disconnection or interruption of an enteral feed. It is typically made of plastic materials and is available in a range of sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-636-6285info@neodevices.com

Regulatory Flags#

DUNS number
189670230
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816340021632EL-SPIKE-MEL-SPIKE-M2026-06-01
00816340021649EL-SPIKE-FEL-SPIKE-F2026-06-01
00816340021656EL-S55-HFEL-S55-HF2026-06-01
00816340023162Transfer StrawND-S552026-02-05
10816340023145Marian MedicalETT-A-15502025-03-28
10816340021523NeoDevices, Inc.ND60-EL2016-09-24
10816340028355NeoDevices, Inc.ND60-EL2016-09-24
00816340023131SS-1660.13SS-1660.132024-04-17
10816340021097NeoDevices, Inc.LN22102016-09-24
10816340021103NeoDevices, Inc.LN22152016-09-24
10816340027921NeoDevices, Inc.LN22102016-09-24
10816340027938NeoDevices, Inc.LN22152016-09-24
10816340022117NeoDevices, Inc.ND-BF202016-09-24
10816340027808NeoDevices, Inc.ND-BF202016-09-24
00816340023124CT KITCT KIT2023-02-09
10816340023121CT KITCT KIT2023-02-09
10816340023008NeoDevices, Inc.ND-S3EL2016-09-24
10816340023015NeoDevices, Inc.ND-S5EL2016-09-24
10816340023022NeoDevices, Inc.ND-S10EL2016-09-24
10816340023039NeoDevices, Inc.ND-S20EL2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01
00816340021649EL-SPIKE-FNEODEVICES INCKNT2026-06-01
00816340021656EL-S55-HFNEODEVICES INCKNT2026-06-01
10192253011210KangarooCardinal Health 200, LLCKNT2026-04-17
10192253006834Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006841Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006858Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253011449CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011555CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011579CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011593CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
10192253011128KangarooCardinal Health 200, LLCKNT2025-05-28
10192253011159CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011173CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011197CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011227CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011258CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011272CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011296CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011104KangarooCardinal Health 200, LLCKNT2025-01-14
G461EGCT36M0EndolumikEndolumik, Inc.KNT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
10192253011319KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011326KangarooCardinal Health 200, LLCKNT2024-06-13