FDA.reportPublic FDA data

NEOMED*

Primary DI
10350770001057
Brand
NEOMED*
Company
Avanos Medical, Inc.
Model
PNM-S1NC
Catalog number
PNM-S1NC
Device description
1mL ENFit Syringe Purp Sterile
Published
2021-04-28
Public version status
New
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
PNREnteral Syringes with enteral specific connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNREnteral Syringes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161039000NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)Neomed, Inc.2016-06-17PNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10350770001057PackageGS1200In Commercial Distribution
00350770001050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077000105710350770001057
00350770001050003507700010503507700010500350770001050

GMDN Terms#

Term, Definition table
TermDefinition
Nasoenteral tubeA sterile, thin, flexible, hollow cylinder designed to access the small intestines (duodenum or jejunum) through the nose and nasopharynx for examination (e.g., of intestinal contents), treatment (e.g., decompression, short-term feeding), or other purposes. It is a single- or dual-lumen, rubber or plastic tube (nasoduodenal or nasojejunal tube) that is smaller and longer than a nasogastric tube and may have a small weight or magnet at the distal tip to facilitate placement. It is frequently used for very ill or comatose patients. Some types are used to remove air and liquids from the stomach by connection to intermittent suction units and/or for enteral feeding. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
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
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
10680651135718Halyard13571PM0062016-08-10
10680651136128Halyard13612PM0022016-08-10
10680651136135Halyard13613PM0032016-08-10
10680651136142Halyard13614PM0042016-08-10
10680651136159Halyard13615PM0052016-08-10
00193494135713ON-Q* Pain Relief System13571PM0062020-05-07
00193494136123ON-Q* Pain Relief System13612PM0022020-05-07
00193494136130ON-Q* Pain Relief System13613PM0032020-05-07
00193494136147ON-Q* Pain Relief System13614PM0042020-05-07
00193494136154ON-Q* Pain Relief System13615PM0052020-05-07
00193493001088SINGLE SHOT EPIDURAL TRAY120008532182A2732026-08-21
00350770006840CORTRAK* Enteral Access System120008508P20-09502026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable Cable12000625220-09662026-08-21
00350770009094CORTRAK* Enteral Access System12000890420-09502026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable Cable12000887220-09662026-08-21
00350770007557CORFLO* Safety PEG Kit12000866230-53202026-08-14
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® Connector120004764BA-S05NC2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® Connector120004831BA-S12NC2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® Connector120004839BA-S60NC2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® Connector120004765BP-S05NC2026-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008929NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008943NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008967NEOMED* At Home Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008981NEOMED* At Home Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770009001NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770009018NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770009032NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770009148NeoMedAvanos Medical, Inc.PNR2026-07-21
00827989008281Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2026-07-10
00827989008298Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2026-07-10
10192253007435MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007503MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007541MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007725MonojectCardinal Health 200, LLCPNR2026-02-19
10850053289672SurgycoSurgyco LLCPNR2025-12-11
10704411006169AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10704411007081AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10704411007104AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10827989004273Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-22
08015262020118NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262020132NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262035419NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262035488NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262039301NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
10192253010923KangarooCardinal Health 200, LLCPNR2025-02-04
10827989000091Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08