Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660218065
• Version / Model: Replacement tubing for 7936E and 7937E
• Catalog Number: 8002E
• Company Name: AMBLER SURGICAL CORP.
• Labeler DUNS: 015272206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-04
• Public Version: 1
• Public Version Date: 2021-01-12
• Public Version Status: New
• Public Device Record Key: 2e85dbe1-2fec-4234-a76f-a44cf65756c3

Device Description

Replacement tubing for 7936E and 7937E

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: No
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMX	Cannula, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47498	Ophthalmic irrigation/infusion/aspiration tubing, reusable	A length of flexible, noninvasive tube intended to connect an ophthalmic cannula to an external device(s) [e.g., pump, bottles] for infusion, irrigation and/or aspiration (suction) during an ophthalmic procedure [e.g., tamponade, glaucoma treatment]. It is made of polymer material(s), may incorporate single- or double-lumen and may be provided in rolls from which required lengths are cut, or in predetermined lengths. It may be provided with simple connectors; however, it does not include other associated items (e.g., clamp, spike) [i.e., not a tubing set]. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660218065	GS1

Customer Contacts

• Phone: [phone] ext. 0
• Email: [email protected]