FDA.reportPublic FDA data

DOUBLE SWIVEL ELBOW 15M - FLIP TOP CAP WITH 7.6MM PORT - 22M/15F

Primary DI
05030267116812
Brand
DOUBLE SWIVEL ELBOW 15M - FLIP TOP CAP WITH 7.6MM PORT - 22M/15F
Company
INTERSURGICAL INCORPORATED
Model
1899000
Device description
DOUBLE SWIVEL ELBOW 15M - FLIP TOP CAP WITH 7.6MM PORT - 22M/15F
Published
2021-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZAConnector, Airway (Extension)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05030267116805PackageGS130In Commercial Distribution
05030267116812PackageGS1120In Commercial Distribution
05030267056040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05030267116805050302671168055030267116805
05030267116812050302671168125030267116812
05030267056040050302670560405030267056040

GMDN Terms#

Term, Definition table
TermDefinition
Tube/mask breathing circuit connector, single-use, non-sterileA non-sterile device intended to connect a breathing circuit breathing tube to an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excluding Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags#

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05030267089123FIXED ELBOW, 15M - 22M/15F - STERILE1997000S2026-04-28
05030267169542SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER11430352026-04-21
05030267169573SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH TUBE, 2.1M USA ONLY11410352026-04-21
05030267169597SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER11430382026-04-21
05030267169634SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO MONITORING LINE AND TUBE11420352026-04-21
05030267056057Y-PIECE 22M, 22M, 22M/15F19000002021-10-12
05030267056095Y-PIECE 22M, 22M, 22M/15F WITH PORTS19010002021-10-12
05030267056118Y-PIECE 15M, 15M, 15F19020002021-10-12
05030267056132Y-PIECE 15M, 15M, 22M/15F + 7.6MM PORTS, PAEDIATRIC19030002021-10-12
05030267056347PARALLEL Y-PIECE, 22MM19260002021-10-12
05030267056361PARALLEL Y-PIECE, 22M/15F -22M-22M WITH PORTS19270002021-10-12
05030267056408ADJUSTABLE Y-PIECE WITH SWIVEL NECK19290002021-10-12
00816472023726CO2 Sampling Line for Microstream® (Oridion®) capnography937160002023-01-13
05030267052257INTER-GUARD BREATHING FILTER WITH SUPERSET CATHETER MOUNT - STERILE1344711S2023-06-15
05030267054114CLEAR-GUARD3 ANGLED BREATHING FILTER WITH LUER PORT AND 22F/15M-22M/15F15450002023-06-15
05030267056279ONE-WAY DIRECTIONAL VALVE 22M FLOW IN-22F FLOW OUT19210002022-11-11
05030267057207T-PIECE, 22M, 22M/15F, 22M, WITH ONE-WAY VALVES19540002023-06-15
0503026706065822MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6M20260002025-03-14
0503026706071922MM FLEXTUBE DUAL H/W B/S WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. >1.6M20263102025-03-14
05030267064823MONITORING LINE 1.8M, MALE - MALE LUER LOCK CONNECTORS27250002024-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923980112799MindrayGaleMed Xiamen Co., Ltd.BZA2026-05-26
06944904007236MindrayGaleMed Xiamen Co., Ltd.BZA2026-05-26
16923980103206N/AGaleMed Xiamen Co., Ltd.BZA2026-05-25
20197344009807HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
44710810084858N/AGALEMED CORPORATIONBZA2026-03-05
44710810086548N/AGALEMED CORPORATIONBZA2026-03-05
44710810102453N/AGALEMED CORPORATIONBZA2026-03-05
44710810104037N/AGALEMED CORPORATIONBZA2026-03-05
44710810110731N/AGALEMED CORPORATIONBZA2026-03-05
44710810082601N/AGALEMED CORPORATIONBZA2026-03-04
44710810083929N/AGALEMED CORPORATIONBZA2026-03-04
44710810086753N/AGALEMED CORPORATIONBZA2026-03-04
44710810087187N/AGALEMED CORPORATIONBZA2026-03-04
44710810104563N/AGALEMED CORPORATIONBZA2026-03-04
44710810107328N/AGALEMED CORPORATIONBZA2026-03-04
44710810111417N/AGALEMED CORPORATIONBZA2026-03-04
44710810115941N/AGALEMED CORPORATIONBZA2026-03-04
00619498004409HumidAirRESMED PTY LTDBZA2026-02-09
04048675034643Connector M34X1.5, 9/16Drägerwerk AG & Co. KGaABZA2026-02-04
04048675034735"Adapter 9/16"" to 6mm"Drägerwerk AG & Co. KGaABZA2026-02-04
20197344012005HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012463HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012593HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344042323HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
46923980107748N/AGaleMed Xiamen Co., Ltd.BZA2025-12-24
46923980107281N/AGaleMed Xiamen Co., Ltd.BZA2025-12-23
20889483225254AirLife™SUNMED, LLCBZA2025-12-22
20889483225223Adapters/ConnectorsSUNMED, LLCBZA2025-12-18
20889483225278AirLife™SUNMED, LLCBZA2025-12-18