Subcutaneous Injection Supply Kit

Primary DI
04046955096763
Brand
Subcutaneous Injection Supply Kit
Company
B. Braun Melsungen Aktiengesellschaft
Model
900-V1US01
Device description
The parenteral administration kit is composed to support the home application of a subcutaneous injection of fluids for medical purposes.
Published
2017-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PORParenteral Administration Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PORParenteral Administration KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955096763PackageGS16In Commercial Distribution
04046955096756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955096763040469550967634046955096763
04046955096756040469550967564046955096756

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)822-7286BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags#

DUNS number
315016972
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955096756Subcutaneous Injection Supply Kit900-V1US012017-08-07
04046955143191Omnican® fine931A04EUS931A04EUS2026-02-10
04046961013075Omnican® fine931M08SEUS931M08SEUS2026-02-10
04046955143184Omnican® fine931A04EUS931A04EUS2026-02-10
04046961013068Omnican® fine931M08SEUS931M08SEUS2026-02-10
04046955635825NORM-JECT®NJ-4606755BMSNJ-4606755BMS2025-07-14
04046955635832NORM-JECT®NJ-4606755BMSNJ-4606755BMS2025-07-14
04046955251704Subcutaneous Injection Supply Kit 2900-V2US012018-09-03
04046955251711Subcutaneous Injection Supply Kit 2900-V2US012018-09-03
04046964905063ACCEL®6222986222982019-10-29
04046964613371ACCEL®6222756222752019-04-20
04046955143115Omnican®931A04US931A04US2021-12-01
04046955138043Omnican®931A04US931A04US2021-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955251704Subcutaneous Injection Supply Kit 2B. Braun Melsungen AktiengesellschaftPOR2018-09-03
04046955251711Subcutaneous Injection Supply Kit 2B. Braun Melsungen AktiengesellschaftPOR2018-09-03
04046955096756Subcutaneous Injection Supply KitB. Braun Melsungen AktiengesellschaftPOR2017-08-07