Spacelabs Healthcare

Basic Information

• Brand Name: Spacelabs Healthcare
• Primary DI: 10841522118142
• Version / Model: DATUM
• Catalog Number: 13012256
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC
• Labeler DUNS: 145581588
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-03
• Public Version: 5
• Public Version Date: 2019-07-12
• Public Version Status: Update
• Public Device Record Key: b29f7a87-bf01-42e3-8949-29d9cbd04d75
• Distribution End Date: 2019-07-12

Device Description

DATUM+ 5% ISO SELECTATEC STD FILL - MEDITEC

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAD	VAPORIZER, ANESTHESIA, NON-HEATED	Anesthesiology	868.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36890	Isoflurane anaesthesia vaporizer	A device used to vaporize the anaesthetic agent isoflurane and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841522118142	GS1

Premarket Submissions

Submission Number	Supplement Number
K942799	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 0 Percent (%) Relative Humidity