FDA.reportPublic FDA data

Emesis Basin - 700 cc

Primary DI
10850007280021
Brand
Emesis Basin - 700 cc
Company
NEWGEN SURGICAL, INC.
Model
NGS700EB-250NS
Catalog number
NGS700EB-250NS
Device description
Emesis Basin, 700cc, non-sterile, EPP/sustainable Designed for use in medical procedures to hold fluids and medical supplies, this product features a biocompatible film coating for added safety. It is durable and strong, with easy-to-read graduations marked in milliliters and cubic centimeters for reference. The product is latex-free and can be sterilized using ethylene oxide (EO). Validated to hold a variety of prep solutions in addition to warm water, cold water, saline, and betadine for up to12 hours.
Published
2026-10-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNYBasin, Emesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850007280021PrimaryGS10
00850007280024Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000728002110850007280021
00850007280024008500072800248500072800240850007280024

GMDN Terms#

Term, Definition table
TermDefinition
Emesis bowl, single-useA device designed as a receptacle for vomit or oral secretions, typically from an immobile patient (e.g., one confined to bed, chair, or wheelchair). It is typically shallow and kidney-shaped, and therefore commonly known as a kidney bowl or basin. It is typically made of disposable plastic materials, and is discarded with its waste contents. The device is also commonly used to hold and transport medical/surgical materials or instruments for a procedure. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
415-457-1138sales@newgensurgical.com

Regulatory Flags#

DUNS number
037689420
Device count
250
DM exempt
false
Premarket exempt
true
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
00850007280284Ring Basin - 5500 ccNGS5500RBE-80NSNGS5500RBE-80NS2026-10-09
10850007280038Sponge Bowl - 32 ozNGS32SB-400NSNGS32SB-400NS2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850007280284Ring Basin - 5500 ccNEWGEN SURGICAL, INC.FNY2026-10-09
10850007280038Sponge Bowl - 32 ozNEWGEN SURGICAL, INC.FNY2026-10-09
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00724995252861V. MuellerSteris CorporationFNY2026-08-21
00724995252878V. MuellerSteris CorporationFNY2026-08-21
00724995252885V. MuellerSteris CorporationFNY2026-08-21
B382SD923302270Surgical DirectSurgical Direct, Inc.FNY2026-08-07
00850083275242Intrace USAPILOTIS TECH LLCFNY2026-07-03
00850083275259Intrace USAPILOTIS TECH LLCFNY2026-07-03
16931918130552AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2026-04-17
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00661392025493LSL HEALTHCARELSL Industries, LLCFNY2025-05-16