AccessGUDID - DEVICE: RECEPTAL™ Suction Procedure Kit (10704411011521)

GUDID

Device Identifier (DI) Information

Brand Name: RECEPTAL™ Suction Procedure Kit
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ELID2-820821
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 10704411011521
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: RECEPTAL™ Suction Procedure Kit EZE-VAC® Disposable Canister with lid, elbows on patient and vacuum port Non-sterile suction tube 3/16 in. ID × 6 ft. (5 mm × 1.8 m) with connnectors Non-sterile suction tube 3/16 in. ID × 18 ft. (5 mm × 46 cm) with connnectors

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44942	Suction system canister liner	A device made of disposable materials used to cover the inner surface of a suction system reusable canister, for the collection of substances such as blood, bodily fluids, rinsing fluids, body tissue, or gas (e.g., laser plume evacuation) from a site of operation. The device may be soft-walled, or it may have walls of semi-rigid plastic with a dedicated lid. Together with the canister, it can be used singularly, or in a connected series to provide greater capacity. This device should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDQ	Bottle, Collection, Vacuum

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0886390a-6da3-492a-b5d0-e827ee5f7cea
Public Version Date: November 19, 2019
Public Version Number: 1
DI Record Publish Date: November 11, 2019