FDA.report

GUARDIAN

Primary DI
20841156110366
Brand
GUARDIAN
Company
TELEFLEX INCORPORATED
Model
IPN926994
Catalog number
8216
Device description
Guardian II NC Model 8216 Pouch Label US TCT
Published
2023-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Product Code Classifications

CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20841156110366PackageGS125In Commercial Distribution
10841156110369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2084115611036620841156110366
1084115611036910841156110369

GMDN Terms

TermDefinition
Haemostasis valveA noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10841268110073Hemostasis Valve AdapterGALT MEDICAL CORP.DTL2026-01-19
10884450312459TRAM®PMerit Medical Systems, Inc.DTL2025-12-23
20197344137487NAMICMEDLINE INDUSTRIES, INC.DTL2025-11-28
10884450662301AccessPLUS™Merit Medical Systems, Inc.DTL2025-09-03
40884389862101MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-08-12
40884389734569MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-08-05
10197344100187NAMICMEDLINE INDUSTRIES, INC.DTL2025-08-04
00194613123406MSI Precision Specialty InstrumentsMed Saver, Inc.DTL2025-08-01
40884389734217MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734385MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734897MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734910MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734927MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734934MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734941MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389875651MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389875682MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40889942872801MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
10884450859718CPS H. Lee SafeSheath® Sealing AdapterMerit Medical Systems, Inc.DTL2025-05-31
30193489068218NAMICMEDLINE INDUSTRIES, INC.DTL2025-05-15
10884450860936PhD™Merit Medical Systems, Inc.DTL2025-05-13
20884450860971Honor®Merit Medical Systems, Inc.DTL2025-05-13
10884450003982PhD™Merit Medical Systems, Inc.DTL2025-04-23
10884450664213Honor®Merit Medical Systems, Inc.DTL2025-04-18
10884450860097AccessPLUS™Merit Medical Systems, Inc.DTL2025-03-28
2088445082130910Fore™Merit Medical Systems, Inc.DTL2025-03-15
20884450818101MBA™Merit Medical Systems, Inc.DTL2025-02-22
1088445083250610Fore™Merit Medical Systems, Inc.DTL2025-02-22
20884450834170Passage®Merit Medical Systems, Inc.DTL2025-02-06
10884450834166Passage®Merit Medical Systems, Inc.DTL2025-01-31