AccessGUDID - DEVICE: Rescuer 7000-AD Replacement Suction Canister kit (B0027000AD0)

GUDID

Device Identifier (DI) Information

Brand Name: Rescuer 7000-AD Replacement Suction Canister kit
Version or Model: 7000-AD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7000-AD
Company Name: B.L.S. Systems Limited

Primary DI Number: B0027000AD0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 200103823 *Terms of Use

Device Description: Replacement canister kit and catheters for 7000-MVP

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?
63644	Emergency airway clearance suction pump, manual	A manually-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure for emergency aspiration of fluids, secretions, or other unwanted materials from the airway of a patient, in conjunction with a handpiece/tip (not included). It is typically used during patient transport or for emergency situations (e.g., placed on a crash cart); it is not intended for surgical use. The pump may include a collection container, microbial filter, valve, or tubing. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSY	Catheters, Suction, Tracheobronchial

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
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5c5a6968-71a6-46d9-9da5-24f60ef3e9c8
Public Version Date: March 20, 2024
Public Version Number: 3
DI Record Publish Date: October 02, 2018