FDA.report

Diapact®

Primary DI
04039239047131
Brand
Diapact®
Company
B. BRAUN MEDICAL INC.
Model
7210511
Catalog number
7210511
Device description
Drain Bags
Published
2015-08-09
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

Related Records

Contact Domains

Product Codes

CodeName
FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Product Code Classifications

CodeDeviceSpecialtyClass
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation ValveGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04039239047131PrimaryGS10
04039239047124Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04039239047131040392390471314039239047131
04039239047124040392390471244039239047124

GMDN Terms

TermDefinition
Haemodialysis blood tubing set, single-useA collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)848-2066rtd.us@bbraun.com

Regulatory Flags

DUNS number
002397347
Device count
24
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
true
Sterilization required before use
false

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108408611025535008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
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108408611026075008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611026215008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
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04046955735280Hemodialysis BloodlinesB. BRAUN MEDICAL INC.FJK2021-07-25
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