FDA.reportPublic FDA data

Pall® Transfer/Freezing Bag Set

Primary DI
00636207302441
Brand
Pall® Transfer/Freezing Bag Set
Company
Global Life Sciences Solutions USA LLC
Model
791-02
Catalog number
791-02
Device description
Two transfer bags (150 mL and 200 mL) and one 25 mL freezing bag for blood component processing and freezing.
Published
2016-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSRCONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSRContainer, Empty, For Collection & Processing Of Blood & Blood ComponentsHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK9800270

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK9800270

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30636207302442PackageGS124In Commercial Distribution
00636207302441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3063620730244230636207302442
00636207302441006362073024416362073024410636207302441

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical cord blood collection setA group of devices intended to be used to collect, process, and store umbilical cord blood and/or umbilical cord blood components (e.g., buffy coat). It typically includes tubing, hollow needles for insertion into the umbilical cord (a double venipuncture of the cord) to collect the blood, and several containers (flexible bags usually containing an anticoagulant) intended for transitional (room temperature) or long-term (frozen) blood storage. The cord blood is usually intended to be frozen and stored, typically to preserve stem cells, for subsequent reinfusion into patients, generally in cases of leukaemia. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume25Milliliter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)645-6578QAMedical@pall.com

Regulatory Flags#

DUNS number
011658242
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00636207300904Pall Posidyne® NEO FilterNEO96NEO962016-06-01
00636207300935Pall Posidyne® NEO FilterNEO96NYNEO96NY2016-06-01
00636207000125Pall Posidyne® ELD FilterELD96NTELD96NT2016-06-01
00636207000231Pall Conserve™ Small Volume HMEBB25ABB25A2016-06-01
00636207000323Pall Posidyne® ELD FilterELD96LLELD96LL2016-06-01
00636207000330Pall Posidyne® ELD FilterELD96LYLELD96LYL2016-06-01
00636207000347Pall Posidyne® ELD FilterELD96LYLSELD96LYLS2016-06-01
00636207000699Pall® Total Nutrient Admixture FilterTNA1TNA12016-06-01
00636207000743Pall Ultipor™ 100 Breathing System FilterBB100ABB100A2016-06-01
00636207300683Pall Ultipor™ 100 Breathing System FilterBB100AFBB100AF2016-06-01
00636207300690Pall Ultipor™ 100 Breathing System FilterBB100APFBB100APF2016-06-01
00636207301192Pall Posidyne® ELD FilterELD96NYSELD96NYS2016-06-01
00636207302434Pall® CellWash/Infusion Bag Set791-03791-032016-06-01
00636207302465Pall® Freezing Bag 25 mL with Separable Chamber791-05791-052016-06-01
00636207302984Ultipor™ 25 Anesthesia Breathing Circuit System FilterBB25ABBB25AB2016-06-29
00636207305466Ultipor™ 25 Anesthesia Breathing Circuit System FilterBB25ABNBB25ABN2016-06-29
00636207311290Pall® Heat and Moisture ExchangerHME40HME402016-06-01
00636207314680Briostor™ Transfer/Freezing Bag Set791-12791-122016-07-20
00636207315182Ultipor™ Anesthesia Breathing Circuit System - Adult Machine KitVM40DLNEXVM40DLNEX2016-06-29
00636207315199Ultipor™ Anesthesia Breathing Circuit System - Adult Machine KitVM40COAXVM40COAX2016-06-29

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Primary DI, Brand, Company table
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