FDA.reportPublic FDA data

NeoBottle

Primary DI
00817584010222
Brand
NeoBottle
Company
NEOMED, INC.
Model
SSNB-CL
Catalog number
SSNB-CL
Device description
NeoBottle Oral Dispenser, Sterile, Clear, 80 mL
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYXDispenser, Liquid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817584010229PackageGS160In Commercial Distribution
00817584010222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081758401022910817584010229
00817584010222008175840102228175840102220817584010222

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.

Contacts#

Phone, Email table
PhoneEmail
886-876-2225info@neomedinc.com

Regulatory Flags#

DUNS number
799772079
Device count
1
Premarket exempt
true
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
10817584013374Fenestrated NeoDrapeND-FSND-FS2020-05-19
10817584013336NeoDrapeNDND2020-05-19
00817584010147NeoMed Oral SyringeBA-S3EO-SBA-S3EO-S2016-09-19
00817584010161NeoMed Oral SyringeBA-S6EO-SBA-S6EO-S2016-09-19
00817584010178NeoMed Oral SyringeBA-S12EO-SBA-S12EO-S2016-09-19
00817584010239NeoBottleSSNB-AMSSNB-AM2016-09-19
00817584011038NeoConnect Oral Administration TipPOA-TNCPOA-TNC2016-09-19
00817584011113NeoBottlePSSNB-AMPSSNB-AM2016-09-19
00817584011120NeoBottlePSSNB-CLPSSNB-CL2016-09-19
00817584011205GravityProPNM-S100EOVPNM-S100EOV2016-09-19
00817584011212GravityProPNM-S20EOVPNM-S20EOV2016-09-19
00817584011274GravityProNM-S20EOVNM-S20EOV2016-09-19
00817584011281NeoMed Oral / Enteral SyringeNM-S60EONM-S60EO2016-09-19
00817584011298NeoMed Oral / Enteral SyringeNM-S35EONM-S35EO2016-09-19
00817584011304NeoMed Oral / Enteral SyringeNM-S20EONM-S20EO2016-09-19
00817584011311NeoMed Oral / Enteral SyringeNM-S12EONM-S12EO2016-09-19
00817584011328NeoMed Oral / Enteral SyringeNM-S6EONM-S6EO2016-09-19
00817584011335NeoMed Oral / Enteral SyringeNM-S3EONM-S3EO2016-09-19
00817584011342NeoMed Oral / Enteral SyringeNM-S1EONM-S1EO2016-09-19
00817584012097NeoConnect Oral / Enteral SyringePNM-S1NCPNM-S1NC2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30813360023654UnoDoseCordica Medical, Inc.KYX2026-10-22
40813360023651UnoDoseCordica Medical, Inc.KYX2026-10-22
10813360023643UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023674UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023681UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023640UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023657UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023671UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023688UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023647UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023678UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023685UnoDoseCordica Medical, Inc.KYX2026-10-20
40813360023644UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023667UnoDoseCordica Medical, Inc.KYX2026-10-06
20813360023664UnoDoseCordica Medical, Inc.KYX2026-10-06
30813360023661UnoDoseCordica Medical, Inc.KYX2026-10-06
MHC18140012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22