Ventlab

Basic Information

• Brand Name: Ventlab
• Primary DI: 10889483086353
• Version / Model: BT2420F
• Company Name: VENTLAB, LLC
• Labeler DUNS: 038305402
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-21
• Public Version: 3
• Public Version Date: 2019-10-21
• Public Version Status: Update
• Public Device Record Key: b0826585-b237-4c72-9347-3711aed1e39c

Device Description

INFANT SAFE SPOT,MASK W/ BAG RESERVOIR, MANOMETER FILTER,PEEP & 25CM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSJ	Mask, Gas, Anesthetic	Anesthesiology	868.5550	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36086	Pulmonary resuscitator, manual, single-use	A non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20889483086350	GS1	Box	10	In Commercial Distribution
Primary	10889483086353	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K953107	000

Device Sizes

Type	Value	Unit	Text
Total Volume	300	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature. Do not get wet.