FDA.reportPublic FDA data

SURGYCO

Primary DI
10850053289702
Brand
SURGYCO
Company
Surgyco LLC
Model
RS000540
Device description
Anesthesia Face Mask Pediatric #2
Published
2024-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
BSJMask, Gas, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850053289709PackageGS1100In Commercial Distribution
10850053289702PrimaryGS10
00850053289705Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085005328970920850053289709
1085005328970210850053289702
00850053289705008500532897058500532897050850053289705

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.

Regulatory Flags#

DUNS number
118768538
Device count
25
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850074089060Surgyco010-VPSB21G22025-12-23
10850074089077Surgyco010-VPSB23G22025-12-23
10850074089084Surgyco010-VPSB25G22025-12-23
10850074089091Surgyco010-VPB23G22025-12-23
10850074089107Surgyco010-VPN01102025-12-23
10850074089114Surgyco010-VPN01202025-12-23
20850074089067Surgyco010-VPSB21G22025-12-23
20850074089074Surgyco010-VPSB23G22025-12-23
20850074089081Surgyco010-VPSB25G22025-12-23
20850074089098Surgyco010-VPB23G22025-12-23
20850074089104Surgyco010-VPN01102025-12-23
20850074089111Surgyco010-VPN01202025-12-23
10850053289672SurgycoSEN102302025-12-11
20850053289679SurgycoSEN102302025-12-11
10850074089053ClinicoLab010-16622025-09-10
10850053289870SURGYCOSSNG00102025-07-11
10850053289887SURGYCOSSNG00152025-07-11
10850053289894SURGYCOSSNG00202025-07-11
10850074089015JDL Sensitive010-12502025-07-11
10850074089022JDL Sensitive010-12602025-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874951085Create BiotechCREATE BIOTECH CO., LTD.BSJ2026-07-21
04719874951092Create BiotechCREATE BIOTECH CO., LTD.BSJ2026-07-21
04719874952204Create BiotechCREATE BIOTECH CO., LTD.BSJ2026-07-21
04719874958657Create BiotechCREATE BIOTECH CO., LTD.BSJ2026-07-21
04719874958664Create BiotechCREATE BIOTECH CO., LTD.BSJ2026-07-21
14026704664983HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704664990HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665003HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665027HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665034HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665164HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665171HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665195HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665201HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
05030267156177ECONOMY, ANAESTHETIC FACE MASK, SIZE 0, NEONATE, NO HOOK RING, 15MIntersurgical IncorporatedBSJ2026-06-10
05030267156184ECONOMY, ANAESTHETIC FACE MASK, SIZE 1, INFANT, NO HOOK RING, 15MIntersurgical IncorporatedBSJ2026-06-10
05030267156191ECONOMY, ANAESTHETIC FACE MASK, SIZE 2, PAEDIATRIC, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
05030267156207ECONOMY, ANAESTHETIC FACE MASK, SIZE 3, SMALL ADULT, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
05030267156214ECONOMY, ANAESTHETIC FACE MASK, SIZE 4, MEDIUM ADULT, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
05030267156221ECONOMY, ANAESTHETIC FACE MASK, SIZE 5, LARGE ADULT, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
05030267156238ECONOMY, ANAESTHETIC FACE MASK, SIZE 6, EXTRA LARGE ADULT, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
10192253071405CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-04-06
10192253071412CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071429CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071436CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071443CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071450CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071467CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10197344137435MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-03-05
10197344131662MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31