FDA.reportPublic FDA data

McKesson

Primary DI
00612479177888
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
19-322160
Device description
Silicone Bulb Evacuator 100mL
Published
2019-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479177888PackageGS110In Commercial Distribution
00612479177871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479177888006124791778886124791778880612479177888
00612479177871006124791778716124791778710612479177871

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drainage kitA collection of sterile devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors, a grasping device and possibly a trocar for placing the drains/catheters into the site. The reservoir will usually be provided with graduated markers along its side to facilitate the approximate measurement of the collected fluids. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10612479235592McKesson16-18502020-06-10
10612479235608McKesson16-18522020-06-10
10612479258317McKesson16-18602020-06-25
10612479258348McKesson16-18622020-06-25
20612479203710McKesson326302020-07-21
10612479169064McKesson101-87032016-12-09
10612479169125McKesson101-87102016-12-09
10612479284002McKesson16-6219-B2026-08-03
10612479284026McKesson16-6218-B2026-08-03
10612479284040McKesson16-6220-B2026-08-03
10612479284064McKesson16-6221-B2026-08-03
10612479284101McKesson16-6379-B2026-08-03
10612479284125McKesson16-6216-B2026-08-03
00612479151291McKesson16-DEN-12026-07-09
00612479274648McKesson48392025-01-17
20612479285723McKessonGCCOV-502a-MB2026-06-18
20612479285747McKessonCCOVAg-PNMB2026-06-18
00612479271050McKesson16-L2NWT6Y-XL2024-04-17
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420060206036haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206043haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206050haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206067haakaaTHINK GREEN LIMITEDGCY2026-09-20
04710969717906Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mL, with Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717913Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717920Uresil Evolution Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159787Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159794Uresil Evolution PRE-VAC WOUND DRAINAGE BOTTLECanadian Hospital Specialties LimitedGCY2026-08-18
04719899159824Uresil Evolution Connecting Tube, with SpikeCanadian Hospital Specialties LimitedGCY2026-08-18
08718104890954Exsudex disposable canisterMeditop B.V.GCY2025-10-17
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00848530106171Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-07-02
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00848530095222Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106201Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106218Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106225Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106232Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106256Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106263Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106270Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530104467Suction KitSunset Healthcare Solutions, Inc.GCY2025-04-14