FDA.reportPublic FDA data

UNIVERSALCONT.25ML W/SCREW &LABEL SI

Primary DI
05713311000113
Brand
UNIVERSALCONT.25ML W/SCREW &LABEL SI
Company
Nunc A/S
Model
364246
Device description
UNIVERSALCONT 25ML W/SCREWC &LABEL SI
Published
2018-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
FMHCONTAINER, SPECIMEN, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713311000113PackageGS16In Commercial Distribution
15713311000110PrimaryGS10
85713311000119Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713311000113057133110001135713311000113
1571331100011015713311000110
8571331100011985713311000119

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA durable, sterile plastic container with ports, or glass bottle, intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. The device provides a suitable closed environment to reduce the risk of contamination and, if applicable, for cell growth/viability during storage that may or may not involve freezing. A device intended for cryopreservation is typically designed for long-term storage in a freezing system. A device intended for culture is typically gas permeable and may have an inner surface that enables adherence. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
305971764
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15713311000073110X16 U CENT.TUBE SCREWCAP PS/PE SI3482242018-08-17
15713311000097UNIVERSALCONT.25ML CAP,SPOON LABEL SI3605852018-08-17
15713311000110UNIVERSALCONT.25ML W/SCREW &LABEL SI3642462018-08-17
15713311000219CryoTube 1,8 ml SI Internal thread Starfoot Round3686322023-06-19
25713311000223CryoTube 1,8 ml SI Internal thread Starfoot Round3686322023-06-19
15713311000103UNIVERSALCONT.25ML W/SCREW CAP SI3642382018-08-17
15713311000202CryoTube 1,8 ml SI Internal thread Starfoot Round3772672023-02-17
25713311000209CryoTube 1,8 ml SI Internal thread Starfoot Round3772672023-02-17
15713311000127NUNC IVF MULTIDISH 4 WELL NUNCLON1444442018-09-21
15713311000134NUNC IVF DISH 35mmNON-TREATED1502552018-09-21
15713311000141NUNC IVF DISH 60mmNON-TREATED1502702018-09-21
15713311000158NUNC IVF DISH 90mmNON-TREATED1503602018-09-21
15713311000165NUNC IVF MULTIDISH4 WELL NON-TREATED1798302018-09-21
05713311000014NUNC IVF MULTIDISH 4 WELL NUNCLON1444441444442016-09-01
0571331100002160X15 IVF PETRID NONTREATED VENTS1502701502702016-09-01
05713311000038IVF 4 WELL DISH NONTREATED1798301798302016-09-01
0571331100004535X10 IVF PETRIDISH NONTREATED VENTS1502551502552016-09-01
0571331100005290X17 IVF PETRIDISH NONTREATED VENTS1503601503602016-09-01
15713311000233CryoTube 1,8 ml SI Internal thread Round3634012022-11-18
15713311000240CryoTube 1,0 ml SI, Internal thread, Conical3666562022-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253051575PrecisionCardinal Health 200, LLCFMH2026-07-09
09555240406361Cell Culture Sampler Wide Cap 2mLITL ASIA PACIFIC SDN. BHD.FMH2026-06-23
00879123009012BFlex™Verathon Medical (Canada) ULCFMH2026-05-29
H1084306551CorningCorning IncorporatedFMH2026-01-26
H1083540141Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540171Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540201Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H108117391CorningCorning IncorporatedFMH2026-01-14
H108117041CorningCorning IncorporatedFMH2025-10-28
10192253051490DoverCardinal Health 200, LLCFMH2025-09-30
10192253051513DoverCardinal Health 200, LLCFMH2025-09-30
10198459304637MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-08-18
10198459382963MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-07-02
10080196035298MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
10198459351327MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-06-02
10198459319990Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-04-18
10193489013467MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-03-20
10198459295270Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-16
10198459277122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-02
10192253051636PrecisionCardinal Health 200, LLCFMH2025-02-19
10198459247897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10198459249303Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10197344039517MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-01-31
10198459203176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-12-08
10198459190544Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-24
10198459179860Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
10198459181702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
H1084313371CorningCorning IncorporatedFMH2024-10-29
H1084313381CorningCorning IncorporatedFMH2024-10-29
H1084313471CorningCorning IncorporatedFMH2024-10-29