FDA.report

22 MM FLEXTUBE SINGLE LIMB TUBE CLIP

Primary DI
05030267100750
Brand
22 MM FLEXTUBE SINGLE LIMB TUBE CLIP
Company
INTERSURGICAL INCORPORATED
Model
2315000
Device description
22 MM FLEXTUBE SINGLE LIMB TUBE CLIP
Published
2021-10-14
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
false

Related Records

Contact Domains

Product Codes

CodeName
BZAConnector, Airway (Extension)

Product Code Classifications

CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267091386PackageGS125In Commercial Distribution
05030267100750PackageGS1100In Commercial Distribution
05030267091379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267091386050302670913865030267091386
05030267100750050302671007505030267100750
05030267091379050302670913795030267091379

GMDN Terms

TermDefinition
Breathing circuit tube holderA device designed primarily to hold the breathing circuit tubing that carries gases from a ventilator and/or anaesthesia system to and from the patient. It is typically fixed to the ventilator/anaesthesia system, but can also be fixed to the patient's bed or medical device service rails (e.g., a wall rail). It is made of metal and plastic materials with adjustable jointed sections. This is a reusable device.

Sterilization Methods

Method

Contacts

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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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05030267123582ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F122300051948502025-09-25
05030267124121ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F122400051948502025-09-25
05030267124077ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F122500051948502025-09-25
05030267124138ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22122600051948502025-09-25
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0503026704595222MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE 519185051918502025-04-16
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0503026716154622mm Compact breathing system21580192025-04-14
0503026716175122mm Compact breathing system21580122025-04-14
05030267166367I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG890300089030002025-04-14
05030267166466I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG.890400089040002025-04-14

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04048675034643Connector M34X1.5, 9/16Drägerwerk AG & Co. KGaABZA2026-02-04
04048675034735Adapter 9/16" to 6mmDrägerwerk AG & Co. KGaABZA2026-02-04
20197344012005HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
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20197344042323HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
46923980107748N/AGaleMed Xiamen Co., Ltd.BZA2025-12-24
46923980107281N/AGaleMed Xiamen Co., Ltd.BZA2025-12-23
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20889483225223Adapters/ConnectorsSUNMED, LLCBZA2025-12-18
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