FDA.reportPublic FDA data

SnapnSeal

Primary DI
00086001047213
Brand
SnapnSeal
Company
Medzah Industries
Model
EVON101
Device description
3oz/90ml 95kpa Specimen Container, Tamper Evident Seal, EO Sterile
Published
2023-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
10860010472139PrimaryGS10
00086001047213Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001047213910860010472139
00086001047213000860010472130860010472130086001047213

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
860-288-8696info@medzah.com

Regulatory Flags#

DUNS number
114193536
Device count
400
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860011917486MEDZAH INSTANT HOT PACKSAM-20002025-07-30
10860012637406MEDZAH INSTANT HOT PACKSAM-20012025-07-30
10860012637413Instant Cold Pack 4.75x7SAM-30002025-08-11
10860012637420Non-Woven Instant Cold Packs 5in x 7.5inSAM-30012025-08-11
00860010472149Instant Cold Pack 6inx9inSAM-10012025-08-11
10860011820168MEDISERVEMSMD012024-07-22
10860011820175MEDISERVEMSMD022024-07-22
10860011820182MEDISERVEMSMD032024-07-22
10860011820199MEDISERVEMSMD042024-07-22
10860011916601MEDISERVEMSMD052024-07-22
10860010472146Instant Cold Pack 6inx9inSAM-10012025-08-11
20860012637410Instant Cold Pack 4.75x7SAM-30002025-08-11
20860012637427Non-Woven Instant Cold Packs 5in x 7.5inSAM-30012025-08-11
10860011343872BIONEXBNMD012025-07-30
10860011343889BIONEXBNMD022025-07-30
10860011343896BIONEXBNMD032025-07-30
10860011725401BIONEXBNMD042025-07-30
10860011725418BIONEXBNMD052025-07-30
10860011917493MEDZAH INFANT HEEL WARMERSAM-1082025-07-30
20860011343879BIONEXBNMD012025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
H1084316231CorningCorning IncorporatedFMH2024-10-29
H1084316241CorningCorning IncorporatedFMH2024-10-29
H1084316251CorningCorning IncorporatedFMH2024-10-29