FDA.report

EMS - Class B Trauma - Bag

Primary DI
00766588160047
Brand
EMS - Class B Trauma - Bag
Company
Certified Safety Manufacturing, Inc.
Model
K616-004
Catalog number
K616-004
Device description
EMS - Class B Trauma - Bag
Published
2019-05-15
Public version status
Update
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

Contact Domains

Product Codes

CodeName
IMDPACK, HOT OR COLD, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00766588160047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588160047007665881600477665881600470766588160047

GMDN Terms

TermDefinition
First aid kit, medicatedA convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(816)483-9090Info@certifiedsafety.com

Regulatory Flags

DUNS number
788460483
Device count
1
DM exempt
false
Premarket exempt
false
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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