FDA.reportPublic FDA data

GOMCO

Primary DI
00260720001767
Brand
GOMCO
Company
ALLIED HEALTHCARE PRODUCTS, INC.
Model
01-22-0309
Catalog number
01-22-0309
Device description
SUCTION/PRESSURE PUMP PORTABLE
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BTAPump, Portable, Aspiration (Manual Or Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00260720001767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00260720001767002607200017672607200017670260720001767

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose suction system, vacuumAn assembly of devices designed to evacuate fluid, tissue, gas, or foreign materials from a body cavity or lumen by means of suction. It is connected via dedicated vacuum tubing to the vacuum terminal unit (wall outlet) of a vacuum pipeline system and powered via a hospital's central vacuum system. It generally includes a regulator, tubing, an overflow trap, plastic/glass collection container(s), a suction tip, and possibly moisture/microbial filters. The regulator controls the vacuum in the suction tubing for the removal of materials into the collection container. This system can be used in a wide variety of hospital settings, but is limited to connection to a central vacuum system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
099674145
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00026072017999PC15008-03P2023-12-22
00026072018002PC15008-03P-A2023-12-22
00026072018019PC15008-03T2023-12-22
00026072018026PC15008-03T-A2023-12-22
00026072018033PC15008-03TP22023-12-22
00026072018040PC15008-03TP2-A2023-12-22
00026072018057PC15008-03Y2023-12-22
00026072018064PC15008-03Y-A2023-12-22
00026072018071PC15008-03YP12023-12-22
00026072018088PC15008-03YP1-A2023-12-22
00026072018095PC15008-03YP22023-12-22
00026072018101PC15008-03YP2-A2023-12-22
00026072018118PC15008-132023-12-22
00026072018125PC15008-13-A2023-12-22
00026072018132PC15008-13P2023-12-22
00026072018149PC15008-13P-A2023-12-22
00026072018156PC15008-13T2023-12-22
00026072018163PC15008-13YP2-A2023-12-22
00026072018170PC15009-032023-12-22
00026072018187PC15009-03-A2023-12-22

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Primary DI, Brand, Company table
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00198715270020GROWNSYOak Tech LLCBTA2024-12-05
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