FDA.reportPublic FDA data

GOMCO

Primary DI
00026072002285
Brand
GOMCO
Company
ALLIED HEALTHCARE PRODUCTS, INC.
Model
01-73-6020
Catalog number
01-73-6020
Device description
THORACIC DRAINAGE PUMP STAND
Published
2016-08-16
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
00026072002285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00026072002285000260720022850260720022850026072002285

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum suction regulator/regulation set, thoracicA noninvasive device/collection of noninvasive devices designed to connect to the terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure during the evacuation of fluids (e.g., blood), secretions, or gases from the pleural cavity and/or mediastinum. The device allows suction at low levels (e.g., 0 - 40 mm Hg), includes a manometer and controls for monitoring/adjusting vacuum pressure, and may include collection containers, or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).

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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00860014577505GROWNSYOak Tech LLCBTA2025-08-26
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06953775661706BBLOVEAlicn Medical Shenzhen, Inc.BTA2025-08-04
07640108052506Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit FussschalterArdo medical AGBTA2025-07-16
07640108053374Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115VArdo medical AGBTA2025-07-16
07640108055293Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115VArdo medical AGBTA2025-07-16
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04250365195071ATMOSATMOS MedizinTechnik GmbH & Co. KGBTA2025-03-25
00810149097911R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-03-04
00810149097850R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-02-13
00812394026043M330Zoll Medical CorporationBTA2025-01-27
07612367008709Vario rail holderMedela AGBTA2024-12-13
00198715270020GROWNSYOak Tech LLCBTA2024-12-05
00810149097645R&D Batteries, Inc.R & D Batteries, Inc.BTA2024-11-15