FDA.reportPublic FDA data

NA

Primary DI
16945155741334
Brand
NA
Company
Ningbo Tianyi Medical Appliance Co., Ltd.
Model
TY-12 BAEO
Catalog number
TY-12 BAEO
Device description
12mL Oral Syringe Amber NonSterile
Published
2024-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945155741337PrimaryGS10
16945155741334Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945155741337069451557413376945155741337
1694515574133416945155741334

GMDN Terms#

Term, Definition table
TermDefinition
ENFit oral/enteral syringe, single-useA manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421148826
Device count
500
DM exempt
false
Premarket exempt
false
HCT/P
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16945155741457NATY-0.5 AEOTY-0.5 AEO2024-02-20
16945155741464NATY-1 AEOTY-1 AEO2024-02-20
16945155741471NATY-3 AEOTY-3 AEO2024-02-20
16945155741488NATY-6 AEOTY-6 AEO2024-02-20
16945155741495NATY-12 AEOTY-12 AEO2024-02-20
16945155741501NATY-20 AEOTY-20 AEO2024-02-20
16945155741808NATY-35 AEOTY-35 AEO2024-02-20
16945155741815NATY-60 AEOTY-60 AEO2024-02-20
06945155741214NATY-0.5 BOEOTY-0.5 BOEO2024-02-20
06945155741221NATY-1 BOEOTY-1 BOEO2024-02-20
06945155741238NATY-3 BOEOTY-3 BOEO2024-02-20
06945155741245NATY-6 BOEOTY-6 BOEO2024-02-20
06945155741252NATY-12 BOEOTY-12 BOEO2024-02-20
06945155741269NATY-20 BOEOTY-20 BOEO2024-02-20
06945155741276NATY-35 BOEOTY-35 BOEO2024-02-20
06945155741283NATY-60 BOEOTY-60 BOEO2024-02-20
06945155741290NATY-0.5 BAEOTY-0.5 BAEO2024-02-20
06945155741306NATY-1 BAEOTY-1 BAEO2024-02-20
06945155741313NATY-3 BAEOTY-3 BAEO2024-02-20
06945155741320NATY-6 BAEOTY-6 BAEO2024-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10827989000107Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000114Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000121Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000138Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000145Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10192253011050KangarooCardinal Health 200, LLCPNR2024-12-02
00020451101309ENFit Syringe 1mlMedela LLCPNR2024-05-06
10192253011036KangarooCardinal Health 200, LLCPNR2024-03-25
10192253008272KangarooCardinal Health 200, LLCPNR2024-03-08
10192253008289KangarooCardinal Health 200, LLCPNR2024-03-08
16945155741457NANingbo Tianyi Medical Appliance Co., Ltd.PNR2024-02-20
16945155741464NANingbo Tianyi Medical Appliance Co., Ltd.PNR2024-02-20
16945155741471NANingbo Tianyi Medical Appliance Co., Ltd.PNR2024-02-20
16945155741488NANingbo Tianyi Medical Appliance Co., Ltd.PNR2024-02-20