FDA.report

Suction Catheter Kits, Disposable

Primary DI
00616784483221
Brand
Suction Catheter Kits, Disposable
Company
Dynarex Corporation
Model
4832
Device description
Suction Catheter Kits, Disposable, Sterile, 12 Fr
Published
2020-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
BSYCatheters, Suction, Tracheobronchial

Product Code Classifications

CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784483238PrimaryGS10
00616784483221Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784483238006167844832386167844832380616784483238
00616784483221006167844832216167844832210616784483221

GMDN Terms

TermDefinition
Secretion suction kitA collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
50
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
false
Sterilization required before use
false

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