FDA.report

Multi Sealer MS 1000

Primary DI
04038917341608
Brand
Multi Sealer MS 1000
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
87.7708.800
Catalog number
87.7708.800
Published
2022-11-30
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

Related Records

Contact Domains

Product Codes

CodeName
KSDDevice, heat-sealing

Product Code Classifications

CodeDeviceSpecialtyClass
KSDDevice, Heat-SealingHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038917341608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917341608040389173416084038917341608

GMDN Terms

TermDefinition
Blood donor bag tube divider/sealerAn electrically-powered device designed to use heat to segment the plastic input tube of a blood donor bag, with automatic sealing of the ends of the divided segments. It may be used to create two or more segments, using heat to make a seal, after which the tube can be transected (e.g., for cross-testing sampling). It is typically used in blood donation centres and blood banks and is available in a variety of forms (e.g., hand-held, desktop); some types have barcode reading and labelling capabilities.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags

DUNS number
388000270
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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