FDA.reportPublic FDA data

PET SHIPPING SYSTEM

Primary DI
00718175001776
Brand
PET SHIPPING SYSTEM
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
001-787
Catalog number
001-787
Device description
Cabinet, Pet, Unit Dose, 0.25" Lead (accommodates lead brick cave)
Published
2018-12-15
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
false

Product Codes#

Code, Name table
CodeName
KPYShield, Protective, Personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00718175001776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175001776007181750017767181750017760718175001776

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding container, transport/transferA radiation protection device specifically designed to shield persons from harmful radiation exposure during air or land based shipping, transfer and delivery of radioactive materials (e.g., radioisotopes) from facility to facility. Designs typically incorporate a container with a lead lining sufficient to attenuate the emissions from the contained radioactive materials, sources, radiopharmaceuticals, or radiation containing devices being transported. This device is used for intra- and inter-hospital transportation of syringes, vials or other devices containing radioisotopes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043833813
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00718175002902LEAD LINED 244-157244-1572020-06-17
00718175002407Biostep 2, 100-240 VAC950-2402024-05-06
00718175006009Reactive Step Trainer 115V950-6002024-05-06
00718175001462Biodex950-146950-1462023-08-02
00718175001486Biodex950-148950-1482023-08-02
00718175005606Sit2Stand950-560950-5602023-07-31
00718175004302VibroTactile950-4302023-07-19
00718175087640BETA, Syringe Shield 007-958007-9582021-01-07
00718175087626VENTI-SCAN IV177-090177-0902020-10-15
00718175087633Aerotech I Radioaerosol Administration System 177-095177-0952020-10-15
00718175002780LEAD LINED 244-136244-1362020-08-26
00718175087619LEAD LINED 244-156244-1562020-08-13
00718175002292LEAD LINED 244-146244-1462020-06-24
00718175004050MJS System 3 Upgrade850-820850-8202017-12-18
00718175002766LEAD LINED 244-206244-2062020-04-13
00718175004708SHIELDED STORAGE CONTAINER050-200050-2002020-04-13
00718175004753SHIELDED STORAGE CONTAINER050-205050-2052020-04-13
00718175004784SHIELDED STORAGE CONTAINER050-250050-2502020-04-13
00718175008478VIAL SHIELD053-610053-6102020-04-13
00718175008614VIAL SHIELD053-611053-6112020-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850061871398IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-01-30
00850061871404IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-01-30
00850061871411IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-01-30
20748426261905Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
20748426261929Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261932Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261956Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
05055449412414KenexKENEX (ELECTRO-MEDICAL) LIMITEDKPY2026-01-20
05055449412407KenexKENEX (ELECTRO-MEDICAL) LIMITEDKPY2026-01-07
10748426143075Medline-MicrotekMicrotek Medical LLCKPY2025-09-25
10748426143464DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-25
10748426143440DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00748426143474DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00748426144273DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00853714008103Steradian ShieldRADUX DEVICES, LLCKPY2025-07-16
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10811042030088BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030095BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030101BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030118BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030125BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030132BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030149BLOXRBLOXR Solutions, LLCKPY2025-06-25