SafetyO2

GUDID 10817494020707

One SafetyO2 Kit Non-rebreather Oxygen Mask with FacePlate and Tubing

GROMAN INC.

Non-rebreathing oxygen face mask

• Primary Device ID: 10817494020707
• NIH Device Record Key: d34cc33d-605b-4d3d-9cb5-253dc0a3e91e
• Commercial Distribution Discontinuation: 2123-03-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafetyO2
• Version Model Number: AM-OXY-FP
• Company DUNS: 020124663
• Company Name: GROMAN INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817494020700 [Primary]
GS1	10817494020707 [Package]; Contains: 00817494020700; Package: Box [25 Units]; Discontinued: 2123-03-01; In Commercial Distribution
GS1	20817494020704 [Package]; Contains: 00817494020700; Package: Box [50 Units]; Discontinued: 2123-03-01; In Commercial Distribution
GS1	30817494020701 [Package]; Contains: 00817494020700; Package: Box [100 Units]; Discontinued: 2123-03-01; In Commercial Distribution

FDA Product Code

• KGB: Mask, Oxygen, Non-Rebreathing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-09
• Device Publish Date: 2023-03-01

Devices Manufactured by GROMAN INC.

• 10817494020691 - SafetyNeb: 2023-03-09 One Kit of SafetyNeb Mask with FacePlate and Nebulizer Tubing
• 10817494020707 - SafetyO2: 2023-03-09One SafetyO2 Kit Non-rebreather Oxygen Mask with FacePlate and Tubing
• 10817494020707 - SafetyO2: 2023-03-09 One SafetyO2 Kit Non-rebreather Oxygen Mask with FacePlate and Tubing
• 50817494020002 - Etchmaster: 2018-07-06 EtchMaster® disposable Large microetching tip prefilled with 50 micron Aluminum Oxide (Color code marking BLACK) with Contra-An
• 40817494020012 - Etchmaster: 2018-07-06 EtchMaster® disposable Large microetching tip prefilled with 50 micron Aluminum Oxide (Color code marking BLACK) with Regular b
• 00817494020021 - Etchmaster: 2018-07-06 EtchMaster® disposable Small microetching tip pre-filled with 50 micron Aluminum Oxide (Color code marking BLACK) with Regular
• 00817494020038 - Etchmaster: 2018-07-06 EtchMaster® disposable Small microetching tip prefilled with 50 micron Aluminum Oxide (Color code marking BLACK) with Contra-An
• 40817494020043 - Etchmaster: 2018-07-06 EtchMaster® disposable Large microetching tip prefilled with 27 micron Aluminum Oxide (Color code marking RED) with Regular ben
• 10817494020059 - Etchmaster: 2018-07-06 EtchMaster® disposable Small microetching tip prefilled with 27 micron Aluminum Oxide (Color code marking RED) with Regular ben