FDA.reportPublic FDA data

Medis

Primary DI
16920687300877
Brand
Medis
Company
Tianjin Medis Medical Device Co.,Ltd.
Model
AC0100B
Device description
Cuff Pressure indicator, with Luer Lock, Blue,Tracheal
Published
2023-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
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
K182548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182548000Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd.2019-01-25BSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16920687300877PackageGS150In Commercial Distribution
26920687300874PackageGS18In Commercial Distribution
06920687300870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692068730087716920687300877
2692068730087426920687300874
06920687300870069206873008706920687300870

GMDN Terms#

Term, Definition table
TermDefinition
Airway pressure monitor, non-poweredA mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8602283963862info@medis-medical.com

Regulatory Flags#

DUNS number
529125266
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06920687310411MedisNF404NF4042024-09-30
06920687310497MedisNF408NF4082024-09-30
06920687310510MedisNF409NF4092024-09-30
16920687310418MedisNF404NF4042024-09-30
16920687310494MedisNF408NF4082024-09-30
16920687310517MedisNF409NF4092024-09-30
06920687300146MedisNF1042023-09-07
06920687300153MedisNF1052023-09-07
06920687300160MedisNF1062023-09-07
06920687300177MedisNF1072023-09-07
06920687300184MedisNF1082023-09-07
06920687300191MedisNF1092023-09-07
06920687300207MedisNF2042023-09-07
06920687300214MedisNF2052023-09-07
06920687300221MedisNF2062023-09-07
06920687300238MedisNF2072023-09-07
06920687300245MedisNF2082023-09-07
06920687300252MedisNF2092023-09-07
06920687308432MedisNF4142023-09-07
06920687308449MedisNF4152023-09-07

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
16920687300884MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
16920687303601MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
10889483002599SunMedSUNMED, LLCBSK2023-07-17
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyBSK2023-04-19
10190676008039POSEYPOSEY PRODUCTS, LLCBSK2023-01-25