FDA.reportPublic FDA data

Subcutaneous Injection Supply Kit

Primary DI
04046955096756
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
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04046955096763PackageGS16Not in 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

Contacts#

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

Regulatory Flags#

DUNS number
315016972
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04046955096763Subcutaneous Injection Supply Kit900-V1US012017-08-07

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
04046955096763Subcutaneous Injection Supply KitB. Braun Melsungen AktiengesellschaftPOR2017-08-07