FDA.reportPublic FDA data

Pall® Transfer/Freezing Bag Set

Primary DI
30636207302442
Brand
Pall® Transfer/Freezing Bag Set
Company
PALL CORPORATION
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
OTC
false
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
002054419
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007036101Pall Ultipor 50U552022-04-20
30636207302435Pall® CellWash/Infusion Bag Set791-03791-032016-06-01
30636207302466Pall® Freezing Bag 25 mL with Separable Chamber791-05791-052016-06-01
30636207314681Briostor™ Transfer/Freezing Bag Set791-12791-122016-07-20
30636207315398Ultipor™ Anesthesia Breathing Circuit System - CO2 Monitoring LineCO2GSL060CO2GSL0602016-06-29
30636207315336Gas Sampling Elbow with CapWMPELBOVMPELBO2016-06-29
30636207300905Pall Posidyne® NEO FilterNEO96NEO962016-06-01
30636207300936Pall Posidyne® NEO FilterNEO96NYNEO96NY2016-06-01
30363207000244Pall® Breathing Circuit FilterBB50TBB50T2016-06-01
35034480004056Pall LeukoGuard LGBLGBLGB2015-10-21
30636207000126Pall Posidyne® ELD FilterELD96NTELD96NT2016-06-01
30636207000232Pall Conserve™ Small Volume HMEBB25ABB25A2016-06-01
30636207000324Pall Posidyne® ELD FilterELD96LLELD96LL2016-06-01
30636207000331Pall Posidyne® ELD FilterELD96LYLELD96LYL2016-06-01
30636207000348Pall Posidyne® ELD FilterELD96LYLSELD96LYLS2016-06-01
30636207000690Pall® Total Nutrient Admixture FilterTNA1TNA12016-06-01
30636207000744Pall Ultipor™ 100 Breathing System FilterBB100ABB100A2016-06-01
30636207300684Pall Ultipor™ 100 Breathing System FilterBB100AFBB100AF2016-06-01
30636207300691Pall Ultipor™ 100 Breathing System FilterBB100APFBB100APF2016-06-01
30636207301193Pall Posidyne® ELD FilterELD96NYSELD96NYS2016-06-01

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Primary DI, Brand, Company table
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