FDA.reportPublic FDA data

1500ML RECEPTAL™ LINER WITH VAC-GARD® AND POUR SPO

Primary DI
40704411000175
Brand
1500ML RECEPTAL™ LINER WITH VAC-GARD® AND POUR SPO
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
430440411
Device description
1500ML RECEPTAL™ LINER WITH VAC-GARD® AND POUR SPOUT
Published
2016-09-23
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
true

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40704411000175PackageGS15In Commercial Distribution
20704411000171PrimaryGS10
00704411000177Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4070441100017540704411000175
2070441100017120704411000171
00704411000177007044110001777044110001770704411000177

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
825673239
Device count
10
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
40704411021088AMSafe® I.V. Administration Set11010802B2025-12-29
40704411020241AMSure® 0.9% Sodium Chloride lrrigation USP 100 mL, Sterile1AS-62402025-12-05
40704411020258AMSure® Sterile Water for lrrigation USP 100 mL1AS-62502025-12-05
00704411020267AMSure® Sterile Water for lrrigation USP 250 mL1AS-62602025-12-05
40704411020272AMSure® 0.9% Sodium Chloride lrrigation USP 250 mL, Sterile1AS-62702025-12-05
40704411020500AMSure® 0.9% Sodium Chloride lrrigation USP 500 mL, Sterile1AS-63802025-12-05
40704411020517AMSure® Sterile Water for lrrigation USP 500 mL1AS-63902025-12-05
40704411020524AMSure® 0.9% Sodium Chloride lrrigation USP 1000 mL, Sterile1AS-64812025-12-05
40704411020531AMSure® Sterile Water for lrrigation USP 1000 mL1AS-64912025-12-05
40704411008829AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716102025-07-02
40704411008836AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716122025-07-02
40704411008843AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716142025-07-02
40704411008850AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716162025-07-02
10704411008866AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971610SS2025-07-02
40704411008874AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971612SS2025-07-02
40704411008881AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971614SS2025-07-02
40704411008898AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971616SS2025-07-02
40704411019542AMSure® Foley Catheter Tray1AS894142025-07-01
40704411019559AMSure® Foley Catheter Tray1AS894162025-07-01
40704411019566AMSure® Foley Catheter Tray1AS894182025-07-01

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