Regard™

Primary DI: 20194717102189
Brand: Regard™
Company: ROI CPS, LLC
Model: GS00401A
Published: 2019-12-23
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: true
Single use: true

Related Records

Product Codes

Code	Name
PXC	Personal Protection Kit

Product Code Classifications

Code	Device	Specialty	Class
PXC	Personal Protection Kit	General Hospital	1

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
20194717102189	Package	GS1	10	In Commercial Distribution
10194717102182	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized
20194717102189	20194717102189
10194717102182	10194717102182

GMDN Terms

Term	Definition
Surgical/examination garment kit	A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Term

Definition

Surgical/examination garment kit

A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number: 117174678
Device count: 1
DM exempt: false
Premarket exempt: true
HCT/P: false
Kit: true
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: false
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

Other Devices From This Company

Primary DI	Brand	Model	Published
20194717102295	Regard™	UR00857C	2019-11-21
20194717120879	Regard™	HT01025G	2024-12-20
20194717120886	Regard™	LD00090U	2024-12-20
20194717120893	Regard™	HT00074Y	2024-12-20
20194717120916	Regard™	GS00802N	2024-12-20
20194717120923	Regard™	OR01102D	2024-12-20
20194717120930	Regard™	OR01103D	2024-12-20
20194717120947	Regard™	GY01330	2025-01-16
20194717120954	Regard™	GY01331	2025-01-16
20194717121098	Regard™	GU01321	2025-01-16
20194717116766	Regard™	OR01109	2023-01-25
20194717116773	Regard™	OR01113	2023-01-25
20194717116780	Regard™	OR01111	2023-01-26
20194717116797	Regard™	OR01114	2023-01-27
20194717116803	Regard™	OR01108	2023-01-27
20194717116810	Regard™	OR01107	2023-01-31
20194717118715	Regard™	OR01103B	2024-02-09
20194717118722	Regard™	OR01102B	2024-02-13
20194717100918	Regard™	OR00355E	2019-12-23
20194717103124	Regard™	OR00095U	2019-11-20

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20194717120077	Regard™	ROI CPS, LLC	PXC	2024-10-02
20194717120138	Regard™	ROI CPS, LLC	PXC	2024-10-02
20194717119910	Regard™	ROI CPS, LLC	PXC	2024-08-14
20194717119743	Regard™	ROI CPS, LLC	PXC	2024-06-20
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20194717116049	Regard™	ROI CPS, LLC	PXC	2022-07-11
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M7526891530	STRADIS HEALTHCARE	STRADIS MEDICAL, LLC	PXC	2022-03-02
00612479259119	McKesson	MCKESSON MEDICAL-SURGICAL INC.	PXC	2022-02-03
00612479259133	McKesson	MCKESSON MEDICAL-SURGICAL INC.	PXC	2022-02-03
00816703025734	MedSource Gloves	MEDSOURCE INTERNATIONAL LLC	PXC	2021-08-03
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00816703028599	MedSource Gloves	MEDSOURCE INTERNATIONAL LLC	PXC	2021-07-22
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10818634024845	Bosma Enterprises	Bosma Enterprises	PXC	2021-07-02
10818634024852	Bosma Enterprises	Bosma Enterprises	PXC	2021-07-02
10818634024869	Bosma Enterprises	Bosma Enterprises	PXC	2021-07-02
10818634024876	AFFLINK	Bosma Enterprises	PXC	2021-07-02
10818634024883	AFFLINK	Bosma Enterprises	PXC	2021-07-02
10818634024890	AFFLINK	Bosma Enterprises	PXC	2021-07-02
10818634024906	AFFLINK	Bosma Enterprises	PXC	2021-07-02
10818634025002	Bosma Enterprises	Bosma Enterprises	PXC	2021-07-02
20194717108839	Regard	ROI CPS, LLC	PXC	2020-12-08