Silhouette

Basic Information

• Brand Name: Silhouette
• Primary DI: 00607411917523
• Version / Model: OTC-104-6 (QTY 1)
• Catalog Number: OTC-104-6 (QTY 1)
• Company Name: SALTER LABS
• Labeler DUNS: 022721133
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-30
• Public Version: 3
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: 6465c3a9-2fe4-4819-8842-542ea10436f1

Device Description

Silhouette Cannula (6Foot) - Quantity 1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
CAT	CANNULA, NASAL, OXYGEN	Anesthesiology	868.5340	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35201	Nasal oxygen cannula, basic	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00607411917523	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Adult

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: N/A