FDA.report

DRAIN-CADDY

Primary DI
00650862199116
Brand
DRAIN-CADDY
Company
ATRIUM MEDICAL CORPORATION
Model
19911
Device description
DRAIN CADDY (Drain Accessories)
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KDQBOTTLE, COLLECTION, VACUUM

Product Code Classifications

CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00650862199116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00650862199116006508621991166508621991160650862199116

GMDN Terms

TermDefinition
Pleural drainage system fluid collector standA device designed to provide stability for one or two chest-drainage containers (bottles or bags) that are connected to a patient via tubing. It is a lightweight framework made of metal and/or plastic materials, typically with partitions for the containers; it may have a handle so that the patient can carry it during ambulation. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
051798999
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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