Large Volume Paracentesis Kit

Primary DI
10893029002004
Brand
Large Volume Paracentesis Kit
Company
GI Supply, Inc.
Model
GIS-28
Catalog number
GIS-28
Device description
The GI Supply Large Volume Paracentesis Kit is intended to be used in conjunction with the GI Supply Paracentesis Pump to remove ascitic fluid from the abdominal cavity. The GI Supply Paracentesis Kit is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis. The Sterile Kit contains standard components required for paracentesis procedure (1) 10cc and (1) 30cc luer locking syringe, (1) filter straw, (1) 3-pack povidone-iodine swabsticks, (1) fenestrated drape, (1) 18Ga and (1) 25Ga 1-½” Needles, (2) 5ml ampuls of 1% Lidocaine, (3) 5ml printed sample vials with caps, (1) #11 blade scalpel, (1) bandage, (5) 4x4” gauze pads and (3) alcohol prep pads; along with specially designed components required to work with the RP Pump (2) 1.6L Drainage bags, (1) Pump Tube set, (1) Paracentesis Device Assembly and (1) 15Ga Needle.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray (Kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970187000RUNYON LARGE VOLUME PARACENTESIS KITGi Supply1997-02-14LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10893029002004PackageGS15In Commercial Distribution
00893029002007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089302900200410893029002004
00893029002007008930290020078930290020070893029002007

GMDN Terms#

Term, Definition table
TermDefinition
Pleurocentesis/paracentesis kitA collection of sterile surgical devices intended for acute (i.e., non-indwelling) therapeutic or diagnostic aspiration of fluids or air from the pleural and/or peritoneal cavities. It includes a dedicated needle, syringe, and appropriate support devices (e.g., dressings, drapes); it does not include a drainage catheter and does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-451-5797customer_service@gi-supply.com

Regulatory Flags#

DUNS number
160990313
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
false
Sterilization required before use
false

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