FDA.reportPublic FDA data

Trinity Sterile, Inc.

Primary DI
00841767105214
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
81651
Device description
IV/LINE KIT
Published
2023-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRSI.V. start kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRSI.V. Start KitGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923361000I.V. START KIT, STERILE, DISPOSABLETrinity Laboratories, Inc.1993-06-28LRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841767105214PackageGS120In Commercial Distribution
10841767105211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767105214008417671052148417671052140841767105214
1084176710521110841767105211

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kit, non-medicatedA collection of devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
154424043
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841767195717Trinity Sterile, Inc.500502026-08-25
10841767104696Trinity Sterile, Inc.826042023-07-28
10841767104795Trinity Sterile, Inc.812112023-06-07
10841767104818Trinity Sterile, Inc.812172023-06-07
10841767104825Trinity Sterile, Inc.812282023-06-07
10841767104849Trinity Sterile, Inc.81229A2023-06-07
10841767104962Trinity Sterile, Inc.812482023-06-05
10841767104979Trinity Sterile, Inc.812492023-06-05
10841767104986Trinity Sterile, Inc.812432023-06-07
10841767105143Trinity Sterile, Inc.816552023-04-04
10841767105181Trinity Sterile, Inc.81254B2023-06-05
10841767105211Trinity Sterile, Inc.816512023-03-29
10841767105327Trinity Sterile, Inc.816642023-06-02
10841767105334Trinity Sterile, Inc.813532023-06-05
10841767106614Trinity Sterile, Inc.813452023-06-05
10841767106621Trinity Sterile, Inc.813712023-06-02
10841767106645Trinity Sterile, Inc.814282023-06-02
10841767106652Trinity Sterile, Inc.814322023-04-05
10841767106720Trinity Sterile, Inc.816632023-04-04
10841767106737Trinity Sterile, Inc.816662023-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956572256CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-25
10809160539019Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.LRS2026-09-25
10198956569799CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-22
10198956573758CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-22
10809160538609HalyardMEDICAL ACTION INDUSTRIES INC.LRS2026-09-22
10809160536773HalyardMEDICAL ACTION INDUSTRIES INC.LRS2026-09-18
10809160536810HalyardMEDICAL ACTION INDUSTRIES INC.LRS2026-09-18
10198956559448CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-04
10198956559523CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-04
10198956537545CARDINAL HEALTHCardinal Health 200, LLCLRS2026-08-26
10198956561113CARDINAL HEALTHCardinal Health 200, LLCLRS2026-08-26
10198956561472CARDINAL HEALTHCardinal Health 200, LLCLRS2026-08-26
10198956534742CARDINAL HEALTHCardinal Health 200, LLCLRS2026-07-31
10198956514669CARDINAL HEALTHCardinal Health 200, LLCLRS2026-07-27
10198956531581CARDINAL HEALTHCardinal Health 200, LLCLRS2026-07-27
10653160394099MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-07-21
10653160394228MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-07-21
10809160527665MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.LRS2026-07-21
10198956436213CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-23
10198956279391CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-08
10198956481039CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-08
10198956430235CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-01
10198956431591CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-01
10198956480223CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-01
M689801101006080-110-10 Saline Lock Kit Case of 10Safeguard US Operating, LLCLRS2026-05-29
M68980110150SALINE LOCK KITSafeguard US Operating, LLCLRS2026-05-29
10653160393634MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
10653160393665MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
10653160393689MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
10653160393719MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27