FDA.report

Emesis Bags With Absorbent Pouch

Primary DI
00840117328525
Brand
Emesis Bags With Absorbent Pouch
Company
DYNAREX CORPORATION
Model
4712
Published
2023-12-16
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
00840117328525PrimaryGS10
00840117328518Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117328525008401173285258401173285250840117328525
00840117328518008401173285188401173285180840117328518

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
500
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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