FDA.reportPublic FDA data

Barrx

Primary DI
10884521546264
Brand
Barrx
Company
Covidien LP
Model
CYTO-KIT-R
Device description
Cytosponge Cell Collection Kit
Published
2018-09-26
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
LDZFIXATIVE, ALCOHOL CONTAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDZFixative, Alcohol ContainingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521546264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452154626410884521546264

GMDN Terms#

Term, Definition table
TermDefinition
Cytology scraper, single-useA wooden, plastic, or metal instrument used to collect a scraping of cells from tissue for the purposes of a diagnostic examination. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521032903BiosynGMT-2262015-09-01
10884521102163Vascufil88864788-05V2015-08-31
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693181723EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-11-19
00673693228299EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-09-04
00673693085465EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00673693556729EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00673693755146EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00860011780571Chemical Service Labs, LLCProtean Resources, LLC.LDZ2024-03-18
00860011780588Chemical Service Labs, LLCProtean Resources, LLC.LDZ2024-03-18
00380740129590AlinityAbbott GmbHLDZ2023-11-16
M84941010Hobbs Medical Saccomanno Cell Transport SystemHOBBS MEDICAL, INC.LDZ2023-06-12
M84941012Hobbs Medical Saccomanno Cell Transport SystemHOBBS MEDICAL, INC.LDZ2023-06-12
00810047420545N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420552N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420569N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420934N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420941N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420958N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420965N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00816085021393Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021409Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021478Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022376Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022444Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022468Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022499Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022512Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085020181Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021423Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021430Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021447Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021454Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11