FDA.reportPublic FDA data

Stronghold

Primary DI
00860002529004
Brand
Stronghold
Company
HAMMER-PLANE INC
Model
SSDD
Catalog number
SSDD
Device description
Stronghold anti-disconnect device for Adult Shiley Flexible and Legacy tracheostomy tubes
Published
2019-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JAYSupport, Breathing Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002529035PackageGS120In Commercial Distribution
00860002529004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002529035008600025290358600025290350860002529035
00860002529004008600025290048600025290040860002529004

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube neck holder, single-useA non-sterile, noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791765001
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860002529011StrongholdADDADD2019-09-26
00860002529028StrongholdPDDPDD2019-09-26
00860002529042StrongholdADDADD2019-09-26
00860002529059StrongholdPDDPDD2019-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15019517382518ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-06-01
15019517382488ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
15019517382495ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
15019517382501ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
04260217220318Circuit Support Arm ECOAmtrion GmbHJAY2026-03-30
04260217220479Vario Lock, Circuit Support Arm, 3 Joints, Bennet FootAmtrion GmbHJAY2026-03-30
10889483228579Capette™SUNMED, LLCJAY2025-12-31
20889483228576Capette™SUNMED, LLCJAY2025-12-31
10889483225462Septal-H™SUNMED, LLCJAY2025-12-16
20889483225469Septal-H™SUNMED, LLCJAY2025-12-16
10889483225431Septal-H™SUNMED, LLCJAY2025-12-15
10889483225448Septal-H™SUNMED, LLCJAY2025-12-15
10889483225455Septal-H™SUNMED, LLCJAY2025-12-15
10889483226506AirLife™SUNMED, LLCJAY2025-12-15
10889483226513AirLife™SUNMED, LLCJAY2025-12-15
10889483228586Capette™SUNMED, LLCJAY2025-12-15
10889483228593Capette™SUNMED, LLCJAY2025-12-15
10889483228609Strapette™SUNMED, LLCJAY2025-12-15
10889483228616Strapette™SUNMED, LLCJAY2025-12-15
10889483228623Capette™SUNMED, LLCJAY2025-12-15
10889483228630Capette™SUNMED, LLCJAY2025-12-15
10889483228647Capette™SUNMED, LLCJAY2025-12-15
10889483228654Strapette™SUNMED, LLCJAY2025-12-15
10889483228661Strapette™SUNMED, LLCJAY2025-12-15
10889483228692SavEar™ SUNMED, LLCJAY2025-12-15
10889483230244AirLife™SUNMED, LLCJAY2025-12-15
00653658009019Marpac IncMarpac, Inc.JAY2025-06-06
10850014574625PreVent Endo HolderPEPPER MEDICAL INC.JAY2025-03-26
10850014574632PreVent Endo HolderPEPPER MEDICAL INC.JAY2025-03-26
00850014574604PreVent Endo HolderPEPPER MEDICAL INC.JAY2025-03-26