FDA.report

Globe Scientific

Primary DI
00840095674331
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
4922
Device description
Specimen bag, zip lock, 6x9" absorbent pad & doc. pouch
Published
2021-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NNIContainer, Specimen, Non-Sterile
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840095630429PrimaryGS10
00840095674331Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095630429008400956304298400956304290840095630429
00840095674331008400956743318400956743310840095674331

GMDN Terms

TermDefinition
Specimen container mailer, non-insulatedA non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities and is intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
106793995
Device count
500
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00840095689533Globe Scientific 154205RS2025-07-07
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00840095689557Globe Scientific 154235RS2025-07-07
00840095689595Globe Scientific 154005F2025-07-07
00840095689601Globe Scientific 154020F2025-07-07
00840095689618Globe Scientific 154035F2025-07-07
00840095689625Globe Scientific 154005FS2025-07-07
00840095689632Globe Scientific 154020FS2025-07-07
00840095689649Globe Scientific 154035FS2025-07-07
00840095689656Globe Scientific 154105FS2025-07-07

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