FDA.report

N/A

Primary DI
B089B891650
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B89165
Catalog number
B89165
Device description
1000CC REUSABLE CANISTER WITH "CHRISTMAS TREE" ADAPTER
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KDQBOTTLE, COLLECTION, VACUUM

Product Code Classifications

CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B089B891650PrimaryHIBCC0

GMDN Terms

TermDefinition
Suction/irrigation system canister/bottle holder, reusableA device intended to be used to hold a dedicated fluid or collection/specimen canister or bottle that is used within a suction and/or irrigation system. This device can be used to mount the canister/bottle(s) to the parent system when it is mobile (on wheels), or to mount the canister/bottle to a medical device service rail system or a wall rail (typically used on the ward). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(770)414-4880info@blackandblacksurgical.com

Regulatory Flags

DUNS number
004382282
Device count
1
DM exempt
true
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
true

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