APA IP Shield™ VL

Basic Information

• Brand Name: APA IP Shield™ VL
• Primary DI: 18885009190216
• Version / Model: 701011
• Catalog Number: 701011
• Company Name: VENNER MEDICAL (SINGAPORE) PTE. LTD.
• Labeler DUNS: 659177273
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-25
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 26e8667d-d4b9-40a7-97f8-c49486d18f13

Device Description

A non-sterile device typically designed as a moulded plastic sleeve intended to be placed over the reusable laryngoscope device during intubation to create a barrier in order to reduce the cleaning time and turnaround time of the laryngoscope blade for reuse

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BRY	Cabinet, Table And Tray, Anesthesia	Anesthesiology	868.6100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46832	Laryngoscope blade cover	A non-sterile device typically designed as a moulded plastic sleeve intended to be placed over the reusable blade and upper portion of the handle of a laryngoscope (i.e., rigid intubation type) during intubation to create a barrier in order to reduce the cleaning time and turnaround time of the laryngoscope blade for reuse. It is typically held in place with a rubber band or clip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28885009190213	GS1	Shipper box	200	In Commercial Distribution
Primary	18885009190216	GS1