FDA.reportPublic FDA data

Bag Decanter

Primary DI
10813079020032
Brand
Bag Decanter
Company
REMINGTON MEDICAL, INC.
Model
9001
Catalog number
9001
Device description
For aseptic decanting of I.V. fluids from flexible containers.
Published
2016-09-21
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
LHISet, i.V. Fluid transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813079020032PackageGS150In Commercial Distribution
00813079020035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081307902003210813079020032
00813079020035008130790200358130790200350813079020035

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous fluid bag spikeA small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle15degree

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-0057Quality@Remmed.com

Regulatory Flags#

DUNS number
788472314
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00813079022671VascuChek Speaker DockVC-SD-01VC-SD-012025-11-27
00813079022688VascuChek KitVC-KIT-02VC-KIT-022025-11-27
10813079022616VascuChek Surgical ProbeVC-SP-01VC-SP-012024-08-23
00813079022626VascuChek TransceiverVC-TRX-01VC-TRX-012024-08-23
00813079022633VascuChek ChargerVC-CH-01VC-CH-012024-08-23
00813079022640VascuChek KitVC-KIT-01VC-Kit-012024-08-23
10813079022654VascuChek Clinical ProbeVC-CP-01VC-CP-012024-08-23
10813079020223Bone Marrow "I" Needle1501-I1501-I2020-09-24
20813079020237Bone Marrow "I" Needle1601-I1601-I2020-09-24
10813079020247Bone Marrow "J" Needle Double Diamond TipJD-1104JD-11042020-09-24
20813079020251Bone Marrow "J" Needle Double Diamond TipJD-1106JD-11062020-09-24
80813079020260Bone Marrow "J" Needle with Double Diamond TipJD-1104-NSJD-1104-NS2020-09-24
20813079020275Guidewire Introducer Needle Winged Base PlateBGWI-1802BGWI-18022020-09-24
20813079020299Guidewire Introducer Needle Winged Base PlateBGWI-1902BGWI-19022020-09-24
20813079020305Guidewire Introducer NeedleGWI-1802GWI-18022020-09-24
10813079020322Guidewire Introducer Needle Square Hub Access NeedleGWI-1820WWGWI-1820WW2020-09-24
20813079020336Guidewire Introducer NeedleGWI-1902GWI-19022020-09-24
10813079020346Guidewire Introducer Needle Square Hub Access NeedleGWI-1902WWGWI-1902WW2020-09-24
10813079020360Breast Needle LocatorBNL-2003BNL-20032020-09-24

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