FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy Comfort Insulin Syringes (1cc)(5/16")(30G)
DI: 00891237001089
·
Model: INS0130-0516
·
HOME AIDE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- Easy Comfort Insulin Syringes (1cc)(5/16")(30G)
- Primary DI
- 00891237001089
- Version / Model
- INS0130-0516
- Catalog Number
- 1089
- Company Name
- HOME AIDE DIAGNOSTICS, INC.
- Labeler DUNS
- 783518983
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-05-12
- Public Version
- 3
- Public Version Date
- 2018-06-13
- Public Version Status
- Update
- Public Device Record Key
- 4c751e0f-9fb6-4f95-a97c-294ca33799ee
Device Description
(1cc)(5/16")(30G) Single use disposable insulin syringes. Includes 100 sterile needles individually wrapped.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35904 | Metered-delivery hypodermic syringe | A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00891237001089 | GS1 | ||||
| Unit of Use | 20891237001083 | GS1 | ||||
| Package | 10891237001086 | GS1 | Case | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-915-0116
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 30 | Gauge | |
| Device Size Text, specify | 1cc | ||
| Length | 0.3125 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Insulin Syringes are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.