FDA.report

Emesis Bag

Primary DI
00616784471037
Brand
Emesis Bag
Company
DYNAREX CORPORATION
Model
4710
Device description
Emesis Bag with Hand Protection, White
Published
2021-09-01
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

Related Records

Product Codes

CodeName
FNYBasin, Emesis

Product Code Classifications

CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784471037PackageGS1240In Commercial Distribution
00616784471013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784471037006167844710376167844710370616784471037
00616784471013006167844710136167844710130616784471013

GMDN Terms

TermDefinition
Emesis bagA disposable device intended to collect and contain a patient's vomit until it is convenient to dispose of it and its contents. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

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