FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10889942318674
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA1636
Catalog number
DYNDA1636
Device description
POST TRACH ADULT
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTOTube, tracheostomy (w/wo connector)
NXATracheotomy Care Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2
NXATracheotomy Care KitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914743000EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIFPertrach1992-07-10BTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889942318674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088994231867410889942318674

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA general-purpose collection of various sterile surgical instruments, dressings, and materials intended to be used to assist a range of surgical procedures across multiple clinical specialities. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11
10812564036381MedlineSYN3872SYN38722026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783011135Premier Decann StopperPREMIER DENTAL PRODUCTS COMPANYBTO2026-05-27
10198956196186CARDINAL HEALTHCardinal Health 200, LLCNXA2025-10-16
10198956173842CARDINAL HEALTHCardinal Health 200, LLCNXA2025-08-22
10198459480379MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NXA2025-08-18
10198956110816CARDINAL HEALTHCardinal Health 200, LLCNXA2025-06-26
10198459359217MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NXA2025-06-02
10198459324130Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-04-18
10198459295102Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-03-16
10197106964163CARDINAL HEALTHCardinal Health 200, LLCNXA2025-03-06
10198459276743Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-03-02
10198459241659Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2025-01-19
10198459194214Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-12-01
10198459140839Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-10-06
10197106676844CARDINAL HEALTHCardinal Health 200, LLCNXA2024-09-26
10198459062438Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-08-06
10195327609306Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-07-29
10198459014383Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-07-29
10198459020827Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NXA2024-07-29
10192253052893ArgyleCardinal Health 200, LLCBTO2024-07-15
10197106486061CARDINAL HEALTHCardinal Health 200, LLCNXA2024-06-10
10197106634820CARDINAL HEALTHCardinal Health 200, LLCNXA2024-05-22
10197106455432CARDINAL HEALTHCardinal Health 200, LLCNXA2024-03-01
10192253052909ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052916ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052923ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052930ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052954ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052978ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052985ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052992ArgyleCardinal Health 200, LLCBTO2024-02-16