FDA.reportPublic FDA data

Professional Medical Surgical Supply, Inc. d / b / a International Direct

Primary DI
00814125010994
Brand
Professional Medical Surgical Supply, Inc. d / b / a International Direct
Company
PROFESSIONAL MEDICAL-SURGICAL SUPPLY, INCORPORATED
Model
600-TKIT
Catalog number
600-TKIT
Device description
Compliance Trach Care Kit, ST
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGVTracheostomy cleaning tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGVTracheostomy Cleaning TrayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814125010991PackageGS130In Commercial Distribution
00814125010994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081412501099110814125010991
00814125010994008141250109948141250109940814125010994

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy kit, single-useA collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight55Gram

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)648-5190ksimanis@promedsupply.com

Regulatory Flags#

DUNS number
042850073
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00898777001227Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V111600-V1112020-08-12
00898777001234Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V112600-V1122020-08-12
00898777001241Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V113600-V1132020-08-12
00898777001258Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V114600-V1142020-08-12
20898777001221Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V111600-V1112020-08-12
10898777001231Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V112600-V1122020-08-12
10898777001248Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V113600-V1132020-08-12
10898777001255Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V114600-V1142020-08-12
00814125010871Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V111-BX600-V111-BX2020-07-24
00814125010888Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V112-BX600-V112-BX2020-07-24
00814125010895Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V113-BX600-V113-BX2020-07-24
00814125010901Professional Medical Surgical Supply, Inc. d / b / a International Direct600-V114-BX600-V114-BX2020-07-24
00814125010024Professional Medical Surgical Supply, Inc. d / b / a International Direct600-NW12600-NW122020-07-24
00814125010031Professional Medical Surgical Supply, Inc. d / b / a International Direct600-NW13600-NW132020-07-24
00814125010048Professional Medical Surgical Supply, Inc. d / b / a International Direct600-NW14600-NW142020-07-24
00814125010475Professional Medical Surgical Supply, Inc. d / b / a International Direct600-NW11600-NW112020-07-24
00898777001340Professional Medical Surgical Supply, Inc. d / b / a International Direct600-SS11600-SS112020-07-24
00898777001944Professional Medical Surgical Supply, Inc. d / b / a International Direct600-SS12600-SS122020-07-24
00898777001951Professional Medical Surgical Supply, Inc. d / b / a International Direct600-SS13600-SS132020-07-24
00898777001968Professional Medical Surgical Supply, Inc. d / b / a International Direct600-SS14600-SS142020-07-24

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Primary DI, Brand, Company table
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50197106916795CARDINAL HEALTHCardinal Health 200, LLCOGV2025-02-04
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04035324061112TRACOE careTracoe medical GmbHOGV2023-06-17
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