FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Argyle
DI: 30884527004625
·
Model: MH00002N
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Argyle
- Primary DI
- 30884527004625
- Version / Model
- MH00002N
- Catalog Number
- MH00002N
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-30
- Public Version
- 4
- Public Version Date
- 2023-08-01
- Public Version Status
- Update
- Public Device Record Key
- 660a09a1-c4bd-47c9-90e0-2fa965c9d410
- Distribution End Date
- 2022-12-27
Device Description
Infant Heel Warmer,No Attachment Tab
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MPO | Infant heel warmer (chemical heat pack) | Physical Medicine | 890.5710 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36816 | Instrument warmer, electric | An electrically-powered heating device intended to warm patient-contact instruments (e.g., rigid endoscopes or trocars) before they are introduced into body orifices or other parts of the body. It typically consists of a tabletop device that has recesses or wells for placement of the instrument insertion portion, a heating element, a thermostat and operating controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884527004628 | GS1 | CASE | 100 | Not in Commercial Distribution | 2022-12-27 |
| Primary | 30884527004625 | GS1 | ||||
| Package | 10884527004621 | GS1 | PACK_OR_INNER_PACK | 25 | Not in Commercial Distribution | 2022-12-27 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile;