FDA.reportPublic FDA data

easycare

Primary DI
00850063404457
Brand
easycare
Company
Synchronis Medical, LLC
Model
4818-90000
Device description
Chest Tube Insertion Kit
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PYIThoracic Catheter Insertion Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYIThoracic Catheter Insertion TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850063404464PackageGS130In Commercial Distribution
00850063404457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063404464008500634044648500634044640850063404464
00850063404457008500634044578500634044570850063404457

GMDN Terms#

Term, Definition table
TermDefinition
Pneumothorax catheter insertion setA collection of devices used to puncture the chest wall to enable insertion of a dedicated catheter for the aspiration of a simple pneumothorax or decompression of a tension pneumothorax. It typically consists of a scalpel to make a stab incision and a needle to assist the entry of the catheter with obturator assembly (to protect the internal organs upon entry). Once the catheter is in place, the needle is retracted to allow the flow of air/fluid from within the chest cavity. The set may contain suture for the attachment of the catheter to the skin. It is typically used for accident and emergency (A&E) situations (immediate care or chest crush injury). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
877.433.9080info@synchronismedical.com

Regulatory Flags#

DUNS number
080160207
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850015884641easycare3200-100003200-100002026-02-20
00850015884757easycare3200-100023200-100022026-02-20
00850015884955easycare3200-100103200-100102026-02-20
00850015884979easycare3200-100123200-100122026-02-20
00850015884993easycare3200-100143200-100142026-02-20
00850063404013easycare3200-100163200-100162026-02-20
00850063404037easycare3200-100203200-100202026-02-20
00850015884658easycare3200-100003200-100002026-02-20
00850015884764easycare3200-100023200-100022026-02-20
00850015884962easycare3200-100103200-100102026-02-20
00850015884986easycare3200-100123200-100122026-02-20
00850063404006easycare3200-100143200-100142026-02-20
00850063404020easycare3200-100163200-100162026-02-20
00850063404044easycare3200-100203200-100202026-02-20
00860000925303easycare3200-100383200-100382026-02-20
00850063404051easycare3200-100223200-100222026-02-13
00850063404075easycare3200-100243200-100242026-02-13
00850063404099easycare3200-100263200-100262026-02-13
00850063404112easycare3200-100303200-100302026-02-13
00850063404136easycare3200-100323200-100322026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M689HHCTUINK01050Chest Tube Insertion KitSafeguard US Operating, LLCPYI2026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 5Safeguard US Operating, LLCPYI2026-05-27
10198956361799CARDINAL HEALTHCardinal Health 200, LLCPYI2026-05-19
10198956471160CARDINAL HEALTHCardinal Health 200, LLCPYI2026-05-08
10198956453777CARDINAL HEALTHCardinal Health 200, LLCPYI2026-05-04
10198956398733CARDINAL HEALTHCardinal Health 200, LLCPYI2026-04-21
00850056748605EMS Chest Tube Insertion Kit, 24FrINTEGRATED MEDCRAFT LLCPYI2026-04-14
10198956402805CARDINAL HEALTHCardinal Health 200, LLCPYI2026-04-07
00842209138296NARNORTH AMERICAN RESCUE, LLCPYI2026-04-07
10198956433625CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-31
10198956421158CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-24
50198956421156CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-24
10198956293809CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-23
50198956293807CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-23
10198956380899CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-09
50198956380897CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-09
00850056748551Finger Thoracostomy KitINTEGRATED MEDCRAFT LLCPYI2026-03-03
10198956392564CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-02
50198956392562CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-02
10198956290310CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-23
50198956290318CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-23
10198956350748CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-13
50198956350746CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-13
00842209137459NARNORTH AMERICAN RESCUE, LLCPYI2026-02-10
10198956353114CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
10198956355569CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
50198956353112CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
50198956355567CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
10198956328396CARDINAL HEALTHCardinal Health 200, LLCPYI2026-01-30
50198956328394CARDINAL HEALTHCardinal Health 200, LLCPYI2026-01-30