FDA.reportPublic FDA data

SunMed

Primary DI
10889483002599
Brand
SunMed
Company
SUNMED, LLC
Model
4-0101-00
Catalog number
4-0101-00
Device description
CUFF INFLATION BULB
Published
2023-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSKCuff, tracheal tube, inflatable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSKCuff, Tracheal Tube, InflatableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102674000CUFF SENTRYVentlab Corp.2011-07-22BSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889483002599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088948300259910889483002599

GMDN Terms#

Term, Definition table
TermDefinition
Artificial airway cuff inflation tubingA length of flexible tube designed to connect cuff inflation devices to deliver air during inflation of the cuff of an endotracheal (ET)/ tracheostomy tube. It typically includes connectors at each end. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483562611BALLARD™227-5227-52025-11-21
10889483564370BALLARD™22108-522108-52025-11-21
10889483564424BALLARD™2255-52255-52025-11-21
10889483564479BALLARD™2260-52260-52025-11-21
10889483564486BALLARD™22606-522606-52025-11-21
10889483564554BALLARD™22703-522703-52025-11-21
10889483564578BALLARD™227036-5227036-52025-11-21
10889483564691BALLARD™227135-5227135-52025-11-21
10889483564875BALLARD™227161863-5227161863-52025-11-21
10889483564882BALLARD™22716186-522716186-52025-11-21
10889483564899BALLARD™22716-522716-52025-11-21
10889483623473BALLARD™22701356-522701356-52025-11-21
10889483623480BALLARD™2270156-52270156-52025-11-21
10889483623558BALLARD™22715-522715-52025-11-21
10889483623565BALLARD™227156-5227156-52026-01-16
10889483563670BALLARD™196-5196-52025-11-20
10889483563700BALLARD™197-5197-52025-11-20
10889483563731BALLARD™198-5198-52025-11-20
10889483563762BALLARD™200-5200-52025-11-20
10889483563861BALLARD™205-5205-52025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16979264200000CuffTrekSHANGHAI LONGMANN TECH CO.,LTD.BSK2026-02-12
36979264200004CuffTrekSHANGHAI LONGMANN TECH CO.,LTD.BSK2026-01-23
03665023001112CuffGuardIDMEDBSK2025-12-19
03665023000948CuffGuardIDMEDBSK2025-12-19
03665023000955CuffGuardIDMEDBSK2025-12-19
03665023000962CuffGuardIDMEDBSK2025-12-19
03665023000979CuffGuardIDMEDBSK2025-12-19
03665023000986CuffGuardIDMEDBSK2025-12-19
03665023000993CuffGuardIDMEDBSK2025-12-19
03665023001020CuffGuardIDMEDBSK2025-12-19
03665023001068CuffGuardIDMEDBSK2025-12-19
03665023002515CuffGuardIDMEDBSK2025-12-19
03665023002522CuffGuardIDMEDBSK2025-12-19
03665023002539CuffGuardIDMEDBSK2025-12-19
03665023002546CuffGuardIDMEDBSK2025-12-19
10197344118441MEDLINEMEDLINE INDUSTRIES, INC.BSK2025-06-13
10197344118458MEDLINEMEDLINE INDUSTRIES, INC.BSK2025-06-13
20197344118448MEDLINEMEDLINE INDUSTRIES, INC.BSK2025-06-13
20197344118455MEDLINEMEDLINE INDUSTRIES, INC.BSK2025-06-13
10618125191533PoseyTIDI PRODUCTS, LLCBSK2024-05-03
20618125191530PoseyTIDI PRODUCTS, LLCBSK2024-05-03
00860010850909Pylant MonitorKal-Med, LLCBSK2023-09-01
06920687300870MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
06920687300887MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
06920687303604MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
16920687300877MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
16920687300884MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
16920687303601MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyBSK2023-04-19
10190676008039POSEYPOSEY PRODUCTS, LLCBSK2023-01-25