FDA.reportPublic FDA data

SURGYCO

Primary DI
00850049784795
Brand
SURGYCO
Company
Surgyco LLC
Model
RS000860E
Device description
ADULT OXYGEN ELONGATED VENTURI MASK MULTI-VENT
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850049784792PrimaryGS10
00850049784795Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004978479210850049784792
00850049784795008500497847958500497847950850049784795

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118768538
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 table
Primary DIBrandModelCatalogPublished
20850074089067Surgyco010-VPSB21G22025-12-23
20850074089074Surgyco010-VPSB23G22025-12-23
20850074089081Surgyco010-VPSB25G22025-12-23
20850074089098Surgyco010-VPB23G22025-12-23
20850074089104Surgyco010-VPN01102025-12-23
20850074089111Surgyco010-VPN01202025-12-23
20850053289679SurgycoSEN102302025-12-11
20850053289877SURGYCOSSNG00102025-07-11
20850053289884SURGYCOSSNG00152025-07-11
20850053289891SURGYCOSSNG00202025-07-11
20850074089012JDL Sensitive010-12502025-07-11
20850074089029JDL Sensitive010-12602025-07-11
20850074089036JDL Sensitive010-12702025-07-11
20850074089043JDL Sensitive010-12802025-07-11
00850053289729SURGYCOPS011730L2024-08-30
00850053289736SURGYCOPS011730XL2024-08-30
20850053289785SURGYCORS0905602024-08-30
00850049784986SURGYCORS0908002024-08-09
00850053289507SURGYCOPS0104452024-08-09
00850053289514SURGYCOPSS102852024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501348OXYGEN MASK Single Use Size 4 with nebulizerASSOMEDIKA, OOOBYG2026-05-26
04816415501355OXYGEN MASK Single Use Size 4 with bagASSOMEDIKA, OOOBYG2026-05-26
04816415501362OXYGEN MASK Single Use Size 4ASSOMEDIKA, OOOBYG2026-05-26
06923980112577MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112584MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112591MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112607MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112690MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112553MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112560MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112645MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112652MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112669MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112706MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112713MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
07045432120462Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120479Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120486Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120493Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120509Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
20885632467407HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
20885632467414HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
20885632467469HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
07045432115987The BAG Mask size 1Laerdal Medical ASBYG2026-01-14
07045432115994The BAG Mask size 2 Laerdal Medical ASBYG2026-01-14
07045432116007The BAG Mask size 3 Laerdal Medical ASBYG2026-01-14
07045432116014The BAG Mask size 4Laerdal Medical ASBYG2026-01-14
07045432116021The BAG Mask size 5Laerdal Medical ASBYG2026-01-14
20889483221669Performance Home MedicalSUNMED, LLCBYG2025-12-31
20889483227265BiFLo™SUNMED, LLCBYG2025-12-30